Clinical Trials
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Orthopaedics
Bone Healing in Healthy and Post-menopausal Osteoporotic Women
Mar 2013Both the pathogenesis and the treatment of osteoporosis may potentially interfere at different levels on the multi-stage complex cascade of events involved in bone healing/regeneration. To our knowledge no human studies have been performed to clarify the potential effect of osteoporosis on post-extraction alveolar healing. The primary outcome of the study is to compare alveolar bone changes in width and height 3 months after tooth extraction in 15 post-menopausal osteoporotic women and 15 healthy pre or post menopausal women by the use of cone-beam computer tomography (CBCT) images. As secondary outcome the investigators put: changes in the external contour of the ridge together with periodontal parameters in the neighbouring teeth, tissue blood perfusion changes during the initial healing (assessed by laser doppler flowmetry) and levels of serum bone resorption/formation markers.
Mortality Following Surgery for Proximal Femoral Fractures (HipMo)
Mar 2013Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses undergoing surgery. It affect most seniors and accompanied by a series of complications. The aim of our retrospective clinical trial is to establish a thirty-day mortality rate after surgical solutions, mortality during hospitalization and compare the types of anesthesia chosen during the performance (general vs. subarachnoid anesthesia).
Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures (1-2-KiWI)
Mar 2013Metacarpal V fractures are injuries of the upper extremities. They occur frequently, primarily in young adults.These fractures are caused by falling on the fist, sports accidents and direct or indirect forces. Surgical intervention is necessary for fractures with a strong palmar angulation of the metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline recommendations decisions about therapy are made taking into account logistical aspects, available hardware, individual expertise and preferences. The objective of the study is to compare the advantages and disadvantages of single versus double Kirschner wires for intramedullary fixation of metacarpal V fractures in order to standardize national therapy procedures. Primary hypothesis: In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with a double Kirschner wire with regard to the functional outcome after 6 month, as measured with the Disabilities of the Arm, Shoulder and Hands Score (DASH).
Hip Fractures Treated With Uncemented Arthroplasties (HUA)
Feb 2013The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties. The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.
Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture
Feb 2013There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal pulses are late symptoms of ACS. Many experts think that effective relief of pain caused by regional anaesthesia (RA) may hide the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA is based on old patient-series and single case-reports. Some of these studies report the symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions in these studies cannot be confirmed by an expert of RA. It is also possible that there are more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS. There are no modern, randomized and controlled studies of the safety of RA in patients with tibial shaft fracture.
Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture
Feb 2013There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal pulses are late symptoms of ACS. Many experts think that effective relief of pain caused by regional anaesthesia (RA) may hide the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA is based on old patient-series and single case-reports. Some of these studies report the symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions in these studies cannot be confirmed by an expert of RA. It is also possible that there are more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS. There are no modern, randomized and controlled studies of the safety of RA in patients with tibial shaft fracture.
RCT: Added Value of Coordinator for the Management of Hip Fracture Patients
Feb 2013To evaluate whether a coordinator increases the optimal management of osteoporotic fracture patients and hip fracture patients.
Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb (PREVOST)
Jan 2013The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old. This open randomized controlled trial aims to compare the BMD or osteoporosis treatment prescription rate at 6 months after inclusion between two groups: "intervention" receiving information on fracture and osteoporosis (oral and written), phone call reminders and written information to give to their family physician, and "control" receiving usual care without information.
Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb (PREVOST)
Jan 2013The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old.
Displaced Femoral Neck Fracture in Elderly Patient. Should Cement be Used for Hip Hemiarthroplasty ? (PIH)
Jan 2013The purpose of this study was to identify the clinical relevance of cementless hemiarthroplasties, compare Harris functional score.The hypothesis is the non-inferiority of cementless hemiarthroplasties compare cemented hemiarthroplasties in order to justify the relevance of cementless hemiarthroplasties in displaced femoral neck fractures.
A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
Nov 2012The primary objective of this study is to evaluate if the effect of administering denosumab (60 mg subcutaneously [SC] every 6 months [Q6M]) is not inferior to that of zoledronic acid (5 mg intravenously [IV] once yearly) in postmenopausal women with osteoporosis previously treated with oral bisphosphonates with respect to change in bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) of lumbar spine at 12 months.
Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
Nov 2012This study will compare the effectiveness of Denosumab treatment Q6M with once yearly Zoledronic Acid treatment on Bone Mineral Density (BMD) at various skeletal sites.
VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)
Oct 2012The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.
An Extension Study to Evaluate Six Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003
Sep 2012• Provide additional information on safety in study subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. • Provide information on the vertebral fracture rate in subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. • Provide additional information on non-vertebral fractures and BMD change associated with six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo.
Evaluation of the Safety and Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Femoral Fractures
Sep 2012Certain types of fractures require surgical intervention that may involve the use of bone grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer from disadvantages such as soft tissue invasion of the fracture area, inadequate blood supply, failure to encourage the production of bone and ectopic bone formation. A guided bone regeneration (GBR) environment may help in solving these clinical concerns. GBR has been widely used in the field of dentistry since the 1980s to provide stable placement for dental implants. The purpose of this study is to evaluate the safety, performance and initial efficacy of Regenecure's, AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.
Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture (FEMO)
Aug 2012This study is designed to compare the outcome of patients with proximal femoral fractures with different perioperative regimes: a group with a multimodal intervention and a control group.
Observational Study of Prolia® in Postmenopausal Women With Osteoporosis
Aug 2012The study is being performed to describe Prolia® patients' medication-taking behavior in a non-interventional routine clinical care setting
Modification of ESIN-osteosynthesis in a Femoral Fracture Model and Its Transmission to Clinical Practice
Aug 2012Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced diaphyseal femoral fractures in children. However, some literature report high complication rates (10-50%) in complex fractures. Data of our own patients with special emphasis on complications showed also mediocre results. Thus, a biomechanical study was conducted to search for modifications. In this study the stiffness with a 3rd nail implanted was compared to the classical 2 C-shaped configuration. For each of the 3 configurations of retrograde ESIN (titanium nails) eight composite femoral grafts (Sawbones®) with an identical spiral fracture were used: 2C configuration (2 C-shaped nails, 2x3.5 mm), 3CM configuration (3rd from antero-medial, + 1x2.5 mm) and 3CL configuration (3rd from antero-lateral, + 1x2.5 mm). Each group underwent biomechanical testing in 4-point bending, IRO/ERO and axial compression (0°/9°). Due to a significantly higher stiffness of 3CL in the anterior-posterior, internal rotation and 9° compression directions implantation of 3 nails became standard treatment for all dislocated femoral fractures at our department. All patients were followed prospectively. The following data was collected: Type of osteosynthesis, any kind of complication (additional procedures like cast or external fixateur, Re-Do operations, misalignment, pseudarthrosis, skin irritation, infection), time until full weight bearing and time until implant removal. At follow-up the legs were controlled for a possible length discrepancy and a possible deviation of axis. Patients` satisfaction was controlled by CSQ (clients satisfaction score, Larsen et al 2002). Further on the Harris Hip Score was used. X-ray controls were done as standard care protocol after 1 and 3-4 months (dependend on age). Level of Evidence IV Keywords: Elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents.
Teriparatide and Risedronate in the Treatment of Patients with Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures
Jul 2012The primary objective of this study is to evaluate if teriparatide 20 μg subcutaneously once daily is superior in reducing the incidence of new vertebral fractures during 24 months of therapy, when compared with risedronate 35 mg orally once weekly, in postmenopausal women with prevalent vertebral fragility fractures.
Study of a National Cohort of Adult Patients With Phenylketonuria (ECOPHEN)
Jun 2012Phenylketonuria (PKU) is a metabolic disease of genetic origin. This is a rare disease (incidence 1 / 16000 births) which is the subject of a systematic neonatal screening in France, because it is treatable by a diet low in phenylalanine. This plan is required upon confirmation of diagnosis and continued until the age of 8 years. The current trend is to continue the scheme at least until adolescence. Unlike other countries, in France there are no recommendations for a plan "for life". Knowledge about the natural history of PKU in adulthood, the effects of pediatric age, the frequency of complicated shapes, and prognostic factors are poorly documented. On the other hand, there is no consensus on the therapeutic management of this disease in adulthood and monitoring that could be directed towards the detection of neurological disorders and nutrition. Social integration and quality of life of adults PKU patients living in France have not been studied.
OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)
May 2012This is an Open-label, prospective, randomized, multi-center post-market study.
A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of AMG 785 in the Treatment of Postmenopausal Women With Osteoporosis
May 2012For the overall study period (12-month double-blind alendronate [ALN]-controlled study period followed by the open-label ALN study period) • To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) in women with PMO • To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of new vertebral fracture in women with PMO
Study to Determine the Efficacy and Safety of AMG 785 in the Treatment of Postmenopausal Women With Osteoporosis
May 2012The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis
Arteos II Study: Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort (ARTEOS2)
Apr 2012The investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort.
Treatment of osteopenia with melatonin: Effects on BMD, muscle strength and quality of life
Apr 2012The aim of the study is to assess the effect of melatonin treatment in patients with osteopenia on BMD, muscle function, quality of life and calcium homeostasis.
Second study on the Effect of Teriparatide on Femoral Neck Fracture Healing
Apr 2012To determine the effect of 6 months of treatment with teriparatide 20 μg/day versus placebo on the proportion of men and postmenopausal women ≥50 years of age with successful fracture healing 24 months after internal fixation of a low trauma femoral neck fracture
A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals
Apr 2012The primary objective in the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy is to demonstrate that treatment with denosumab 60 mg subcutaneously (SC) every 6 months (Q6M) is not inferior to treatment with oral risedronate 5 mg every day (QD) with respect to the percent change from baseline in lumbar spine bone mineral density (BMD) by dual X-ray absorptiometry (DXA) at 12 months. The primary objective in the glucocorticoid-initiating subpopulation of men and women treated with glucocorticoid therapy is to demonstrate that treatment with denosumab 60 mg SC Q6M is not inferior to treatment with oral risedronate 5 mg QD with respect to the percent change from baseline in lumbar spine BMD by DXA at 12 months.
A Multicenter, International, Randomized, Double-blind, Placebo controlled, Parallel-group Study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women With Osteoporosis
Mar 2012To assess the effect of AMG 785 treatment for 12 months compared with placebo on the subject incidence of new vertebral fracture
Prevention of postoperative bleeding: A multicenter, randomized, parallel, controlled clinical trial, evaluating the efficacy of tranexamic acid and fibrin glue in patients undergoing interventions for sub-capital femoral fracture.
Feb 2012To assess whether tranexamic acid or fibrin glue administered topically reduce by at least 25% blood loss with respect to control in patients undergoing subcapital fracture of the femur.
The effect of 1-84 parathyroidhormone in the treatment of proximal fracture of the humerus.
Feb 2012To assess the value of treatment with Preotact in patients with humerus fracture.
Effect of Teriparatide on Femoral Neck Fracture Healing
Feb 2012To determine the effect of 6 months of treatment with teriparatide 20 μg/day versus placebo on the proportion of men and postmenopausal women ≥50 years of age with successful fracture healing 24 months after internal fixation of a low trauma femoral neck fracture
Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy (BILANZ)
Jan 2012The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients – a pilot study
Jan 2012To determine whether intravenous iron given in the first few days following hip fracture is effective in stimulating red cell production.
The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients – a pilot study
Jan 2012To determine whether intravenous iron given in the first few days following hip fracture is effective in stimulating red cell production.
A Blinded Extension to 5 Years of a Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium
Dec 20111) To assess the effect of treatment up to 5 years with odanacatib on the risk of morphometrically assessed vertebral fractures compared to placebo. 2) To assess safety and tolerability of treatment up to 5 years with odanacatib 50 mg once weekly compared to placebo.
Multicentre, randomized, open-label, two-arm parallel groups, active controlled study design to demonstrate efficacy and tolerability of clodronate 200 mg/4 ml solution for intramuscular use with 1% lidocaine every other week vs clodronate 100 mg/3,3ml solution for intramuscular use with 1% lidocaine once-week in a 1-year treatment period of women with postmenopausal osteoporosis
Nov 2011To demonstrate that disodium clodronate 200 mg/4 ml solution for i.m. use with 1% lidocaine administered every other week is not-inferior to disodium clodronate 100 mg/3,3 ml for i.m. use with 1% lidocaine administered once-week in terms of lumbar Bone Mineral Density (BMD).
Effectiveness of hyperbaric oxygen therapy in the treatment of the open tibial fractures. Open clinical trial, randomized, prospective and controlled.
Nov 2011To investigate whether hyperbaric oxygen therapy in patients with open fracture of tibia grade II and III decreases the rate of surgical complications (necrosis, dehiscence, infection).
Comparison of the effect of an ongoing treatment with alendronate or a drug holiday on the fracture risk in osteoporotic patients with a bisphosphonate long term therapy
Sep 2011Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?
Is regional anaethesia of the hip preferable over traditional analgesia in the acute stage of the management of patients with a fracture of the hip?
Aug 2011Pain management in patients with a fracture of the hip
A 24 months, prospective, randomized, double-blind study to assess the effect of daily oral administration of 2 g of strontium ranelate versus placebo on bone mineral density in postmenopausal osteoporotic women previously treated with oral bisphosphonates
Aug 2011To demonstrate the effect of strontium ranelate versus placebo of treatment on the areal bone mineral density (BMD) of the lumbar spine in postmenopausal women with osteoporosis previously treated with oral bisphosphonates.
Fractures and Bisphosphonates: A double-blind, randomised controlled trial on the effect of alendronic acid on healing and clinical outcomes of wrist fractures
Aug 2011The aim of the study is to determine if alendronic acid - the drug most commonly used in the UK as treatment of osteoporosis (thinning bones) - affects fracture healing. Participants will be randomised to receive either alendronic acid or a placebo (a tablet that contains no active drug). The main objective will be to look at the x-rays that are taken 4 weeks into the study and compare the number of healed fractures in each group (alendronic acid or placebo). We will also look at how long it takes a fracture to heal, using the x-rays taken at weeks 2, 4, 6 and 8. One person will analyse all the x-rays in the study. The x-rays will be anonymised so that the reviewer is unaware of individual details or the treatment that the participant received.
Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients with Orthopaedic Surgery and High Risk of Blood Loss
Mar 2011The main objective of this study is to evaluate the effect of the administration of ferric carboxymaltose on transfusion requirements (units of packed cells)
A Randomized, Double-blind, Placebo-controlled, Comparative Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of BA058 for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women with Severe Osteoporosis and at Risk of Fracture
Jan 2011Determine the comparative safety and efficacy of 18 months of treatment with BA058 80 µg on reduction of vertebral fracture incidence in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis when compared with Placebo.
Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer
Jan 2011The goals of this pilot study are to estimate the prevalence of secondary causes of osteoporosis in a cohort of patients with nonmetastatic breast and prostate cancer with osteopenia and osteoporosis.
A Double-Blind, Randomized, Repeat Dose, Parallel Group Study of Recombinant Human Parathyroid Hormone (rhPTH(1-31)NH2) tablets, or Placebo tablets, Compared to Open Label Forsteo in Postmenopausal Women with Osteoporosis
Jan 2011To characterize percent change from baseline in bone mineral density (BMD) at L1-L4 axial lumbar spine after 24 weeks of once daily treatment of 5 mg tablets of rhPTH(1 31)NH2.
Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action. A two year open label single arm study of teriparatide in secondary care.
Aug 20101. What is the effect of teriparatide on the axial and appendicular skeleton and on cortical and trabecular bone as assessed by QCT? 2. What are the time course and the magnitude of effect of teriparatide on biochemical markers of bone turnover?
A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to reduce the Risk of Fracture in Osteoporotic Men Treated with Vitamin D and Calcium
Jun 2010(1) To assess the effect of odanacatib 50 mg once weekly versus placebo on lumbar spine BMD over 24 months; (2)To assess the safety and tolerability of odanacatib 50 mg once weekly compared to placebo.
Effect of strontium ranelate (2g per day) in the management of lower limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis
Apr 2010To assess the effects of strontium ranelate in the management of aseptic fractures of the lower limbs with delayed union or non-union.
Effect of strontium ranelate (2g per day) in the management of lower limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis
Apr 2010To assess the effects of strontium ranelate in the management of aseptic fractures of the lower limbs with delayed union or non-union.
A multicenter, prospective, randomized, double-blind, placebo-controlled, international study to assess the effects of 2g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women.
Mar 2010To demonstrate the efficacy of S12911 versus placebo in accelerating radiological healing of distal radius fractures as defined by the bridging in at least 3 out of 4 cortices
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults with a Fresh Unilateral Hip Fracture, Status Post Surgical Fixation
Mar 2010To investigate the effect of AMG 785 compared to placebo on functional healing as measured by the timed-up-and-go test (TUG) over Weeks 6 through 20 in subjects with fresh unilateral low energy hip fractures.
An international, multi-centre, randomized, controlled trial evaluating the effect of xenon on post-operative delirium in elderly patients undergoing hip fracture surgery.
Mar 2010The primary objective is to evaluate the incidence of post-operative delirium (POD, diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia, with Xenon or Sevolfurane, for a period of four days post-surgery
The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D insufficiency in the treatment of osteoporotic postmenopausal women and men. A prospective, international phase III study with a 6-month double-blind period to assess the efficacy and safety of a daily oral administration of S06911 versus S12911 (strontium ranelate 2g) and a 6-month open-labelled extension for a subgroup of patients to assess safety of a daily oral administration of S06911.
Nov 2009To assess the efficacy of S6911 after 3 months of treatment
Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer
Aug 2009The purpose of this study is •to determine the rate of osteoporosis among patients with advanced prostate cancer. •to propose an algorithm for early detection of patients with advanced prostate cancer who are at risk of developing osteoporosis
A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated with Daily or Weekly Bisphosphonates.
Jul 2009To evaluate the change in total hip Bone Mineral Density (BMD) at 12 months in postmenopausal women transitioning from previous daily or weekly bisphosphonate therapy to denosumab 60 mg SC Q6M compared to that in subjects transitioning to ibandronate 150mg PO QM.
A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned from Weekly or Daily Alendronate Therapy.
Jun 2009The primary objective of the study is to evaluate the effect of denosumab 60 mg every 6 months (Q6M) compared with Actonel® 150mg monthly (QM) on total hip Bone Mineral Density (BMD) at 12 months in postmenopausal women transitioning from previous alendronate therapy.
A Substudy to Explore Biomarkers of Physical Function in the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated with Vitamin D and Calcium
Mar 2009To evaluate the phenotypic distribution of aLBM, SPPB, and gait speed in the study population. Specifically to determine if, at baseline, measured traits (aLBM, SPPB and/or gait speed) form an appropriate distribution. To identify biomarkers of sarcopenia by evaluating low aLBM, low SPPB, and low gait speed, separately and in combination, by examining DNA and RNA in circulating blood.
Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)
Nov 2008The purpose of this study is to rigorously test the incremental impact of simple, generalizable interventions to improve healthcare among older women at high risk for osteoporosis
An Imaging Sub-Study of the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium
Sep 2008In postmenopausal women with osteoporosis: To estimate the effect of treatment with MK-0822 50 mg once weekly (OW) on volumetric trabecular bone mineral density (vBMD) at the lumbar spine (assessed by QCT) at Month 12, Month 24, and end of study.
The Relationship between Osteoporosis and Aortic Calcification in Postmenopausal Women
Apr 2008To evaluate the effects of bisphosphonate alendronate on aortic calcification in postmenopausal women with osteoporosis and severe osteopenia.
The efficacy and safety of 2g strontium ranelate in the treatment of male osteoporosis. A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year.
Sep 2007To demonstrate the efficacy over 1 year of strontium ranelate compared to placebo on lumbar BMD in men with osteoporosis.
Influence of urinary acidification by l-Methionine on bone metabolism and acid base status
Jun 2007To assess the impact of l-methionine intake on bone metabolism.
A double-blind, multicenter, international randomised study to assess the effects of 6 months or 12 months administration of 2g per day of strontium ranelate versus alendronate 70mg per week on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis
Feb 2007To assess the effects of 6 or 12 months treatment of strontium ranelate in comparison with alendronate on bone formation assessed by histomorphometry on transiliac paired biopsies performed in patients with postmenopausal osteoporosis treated for 1 year.
A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of rhBMP-2/CPM as an Adjuvant Therapy in Closed Fractures of the Humerus
Nov 2006Demonstrate that fracture union is accelerated in subjects with humeral fractures (proximal, shaft) treated with conservative (nonoperative) therapy SOC and a single dose of rhBMP-2/CPM (either 1.0 or 2.0 mg/mL) compared to subjects who are treated with SOC alone
Addressing Vertebral Osteoporosis Incidentally Detected to Prevent Future Fractures (AVOID Fracture)
Oct 2006The intent of this research is to improve quality of care for patients at high risk of fracture, by increasing rates of testing and treatment of osteoporosis.
Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
Jul 2006The aim of the ROCQ programme is to improve the use of evidence based osteoporosis diagnostic and treatment strategies for women 50 years and over who have suffered a fragility fracture.
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