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Osteoporosis clinical trials

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NCT ID: NCT02060747 Completed - Clinical trials for Osteoporosis, Management Care, Fracture

Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture.

OPTIPOST
Start date: July 1, 2013
Phase: N/A
Study type: Interventional

Harrington's metaphorical depiction captures the essence of the problem : "Osteoporosis care of fracture patients has been characterized as the Bermuda Triangle made up of orthopaedists, primary care physicians and osteoporosis experts into which the fracture patient disappears". The most effective way to achieve this goal is through implementation of coordinator-based post fracture models of care. Exemplar models have been refered to as "Fracture Liaison Service" (United-Kingdom [1-3], Europe [4,5] and Australia [6-8]) "Osteoporosis Coordinator Program" (Canada [9,10]) or "Care Manager Programs" (USA [11,12]). The objective of this trial is to assess efficacy of a new coordinator-based post-fracture program in the Saint-Joseph Hospital in Paris to improve the management of osteoporosis after fracture thanks to an optimal recommendations practice to reduce the incidence of secondary fractures. Men and women are included aged over 45 years with fragility wrist and hip fractures. Evaluation criteria are based on the evidence-based assessment (stratify risk, identify secondary causes of osteoporosis, fracture evaluation), the medication adherence, others prescriptions adherence (osteodensitometry), the incidence of secondary fractures and number of falls. Number of patients : 200 Duration of the study: 3 years Patients' participation duration: 6 months

NCT ID: NCT02058420 Completed - Osteoporosis Clinical Trials

Tocotrienols and Bone Health of Postmenopausal Women

Start date: February 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance for bone fractures. Women are 4 times more likely to have osteoporosis than men because there is no estrogen protection after menopause and women in general have lighter and thinner bones. Recent studies have indicated tocotrienols (one kind of vitamin E) supplement may be good for the bone health in postmenopausal women. However, no study has ever been done the role of tocotrienols in bone health in postmenopausal women. Our long-term goal is to develop a new strategy featuring a dietary supplement (i.e., tocotrienols) for slowing down bone loss in postmenopausal women. The purpose of the study is to examine the effect of 12-week tocotrienols on bone measurements in postmenopausal women. Investigators plan to recruit postmenopausal women using flyers, non-solicited e-mail system, campus announcement, local radio, newspapers, and TV scripts. We plan to enroll approximately 200 women to obtain 78 qualified women at the start of the study. After screening, qualified participants will be matched by body weight and age, and then randomly assigned to no tocotrienols, low tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline, after 6, and after 12 weeks. Bone-related measurements will be recorded using blood and urine samples. Investigators will monitor safety of subjects after 6 and after 12 weeks. Food intake, physical activity, and quality of life will be assessed at baseline and 12 weeks. All data will be analyzed statistically.

NCT ID: NCT02049866 Completed - Clinical trials for Adult Idiopathic Generalized Osteoporosis

Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP

Start date: November 19, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis. Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6 months). The goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. This study presents the first opportunity to study the effects of denosumab after TPTD in this unique and severely affected group of young women. Funding Source: FDA Office of Orphan Products Development (OOPD).

NCT ID: NCT02047864 Completed - Osteoporosis Clinical Trials

Effect of Creatine Supplementation and Exercise on Bone Health

Start date: January 2014
Phase: N/A
Study type: Interventional

Osteoporosis is an important health problem, costing the Canadian health care system over $2 billion per year. Loss of bone mineral and bone fragility is especially prevalent in postmenopausal women. Of all osteoporotic fractures, hip fractures are the most traumatic. Creatine monohydrate is a nutritional supplement that is often combined with strength training to increase strength and muscle mass. The investigators recently completed a pilot study in a small number of postmenopausal women (n=33) that showed that creatine monohydrate significantly improved hip bone mineral density during a 1-year resistance training program. In our current proposal the investigators want to determine whether creatine combined with strength training can have an even larger effect on bone mineral density at the hip if given over 2 years in a large group of postmenopausal women (n=240). The investigators also want to determine whether this leads to reduced fractures in these women for up to a year after completing the creatine and strength training program.

NCT ID: NCT02042872 Completed - Disuse Osteoporosis Clinical Trials

Zoledronic Acid Administration in Acute Spinal Cord Injury

Start date: May 2006
Phase: Phase 4
Study type: Interventional

In subjects with acute SCI: To compare the effects of parenteral zoledronic acid therapy on preservation of regional and total skeletal mass (DXA). Hypothesis: Zoledronic acid will dramatically diminish bone loss in persons with acute SCI, as evidenced by serial densitometry determinations (DXA).

NCT ID: NCT02028702 Completed - Osteoporosis Clinical Trials

Alternative Treatments for Menopausal Women

Start date: June 2012
Phase: N/A
Study type: Interventional

To investigate the reported health benefits (lipid profile, inflammatory factors, cardiovascular status and bone density) of a novel, phytoestrogen rich, Red Clover treatment on women suffering from both menopause related primary (hot flushes, night sweats, sleep disturbance and weight gain) and secondary (osteoporosis, cardiovascular and changes in lipid metabolism) symptoms.

NCT ID: NCT02025179 Completed - Osteoporosis Clinical Trials

12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)

Start date: January 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if a second year of exposure to teriparatide in both subjects that received a year of teriparatide or teriparatide-placebo will result in a greater increase in bone mass density (BMD) compared to that seen in a single year's treatment. This study will also investigate 1) if a second year of teriparatide therapy will increase bone strength in people with chronic spinal cord injury (SCI) who previously received a year of teriparatide or teriparatide-placebo, 2) the number of participants with adverse events from teriparatide, and 3) the effects of teriparatide on serum markers of bone metabolism.

NCT ID: NCT02017067 Completed - Osteoarthritis Clinical Trials

The Effect of Exercise Training in the Community-dwelling Adults With Chronic Disorders

Start date: April 2012
Phase: N/A
Study type: Interventional

Previous studies have demonstrated that resistance training (RT) is beneficial to increase muscle strength, improve functional ability and the ability to rapidly produce force, known as the contractile rate of force development (RFD) in older adults. However, much less research has focused on the effect of RT on the lower extremity muscle strength, contractile RFD and impulse in middle-aged and older people with musculoskeletal conditions, especially for osteoporosis (OP) (or osteopenia) or knee osteoarthritis (KOA). Therefore, the purpose of this study was to investigate the effect of RT on the lower extremity muscle strength, RFD and impulse in middle-aged and older people with musculoskeletal conditions, especially for OP and knee OA (KOA). The investigators hypothesized that such a training program would lead to induce not only specific muscle strength enhancement but also an increment in contractile RFD and impulse.

NCT ID: NCT02016716 Completed - Clinical trials for Postmenopausal Osteoporosis

A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

Start date: December 3, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

NCT ID: NCT02014467 Completed - Clinical trials for Osteoporosis, Postmenopausal

Denosumab China Phase III Study

Start date: January 2014
Phase: Phase 3
Study type: Interventional

This study is to evaluate the efficacy and safety of denosumab 60mg for 12 month treatment in Chinese postmenopausal women with osteoporosis at increased risk of fracture.