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Osteoporosis clinical trials

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NCT ID: NCT01935232 Terminated - Osteoporosis Clinical Trials

Bindex Ultrasonometer for Osteoporosis Diagnostics

Start date: August 2013
Phase: N/A
Study type: Observational [Patient Registry]

Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after a fracture. We expect with our aging population to see a significant increase in the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and do not receive treatment for their condition. This research plan describes a study for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study, the technique has been validated in a Finnish postmenopausal woman population of 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral neck bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA. For validation of the technique in US population, our study plan is presented for determination of diagnostic thresholds for osteoporosis. Taken together, DI with Bindex, lumbar spine and femoral bone BMD with DXA are obtained from 500 postmenopausal women and 140 men. The study will be carried out at the HealthEast Osteoporosis Care service in Woodbury, MN. 1. To investigate the capability of DI for prediction of proximal femur and lumbar spine BMD; 2. To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference population (American-Caucasian) of 500 (if prevalence of osteoporosis is 20%) post-menopausal females (50-90 years); 3. To investigate ability of Density Index + FRAX with BMI in fracture risk prediction; 4. To investigate correlation between lumbar spine or proximal femur BMD and Density Index in 140 men at wide age range (20-90 years), 70 with osteoporosis and 70 with normal or low bone mass. Determine diagnostic thresholds for DI in men.

NCT ID: NCT01803607 Terminated - Osteoporosis Clinical Trials

Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076)

Start date: March 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (BMD) over time in female participants who have received at least 3 years of bisphosphonate therapy.

NCT ID: NCT01630616 Terminated - Osteoporosis Clinical Trials

A Study of Odanacatib When Administered to Adolescents and Young Adults Treated With Glucocorticoids (MK-0822-066)

Start date: March 12, 2013
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of single doses of odanacatib in mature adolescents and young adults who are currently receiving glucocorticoid therapy. The primary hypotheses for the study are that a single dose of odanacatib is well tolerated in mature adolescents and following single dose administration of odanacatib 50 mg, there is no clinically important difference in AUC0-inf between mature adolescents and young adults.

NCT ID: NCT01512446 Terminated - Osteoporosis Clinical Trials

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
Start date: February 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.

NCT ID: NCT01426555 Terminated - Osteoporosis Clinical Trials

FES-Rowing Versus Zoledronic Acid to Improve Bone Health in Spinal Cord Injury (SCI)

Start date: February 2011
Phase: Phase 2/Phase 3
Study type: Interventional

This is a research study to determine the effects of functional electrical stimulation (FES) rowing and a drug called zoledronic acid in bone health. The investigators hoped to learn if zoledronic acid treatment will increase bone mineral density in persons with chronic spinal cord injury (SCI) who received it. The investigators also want to find out if zoledronic acid is safe for persons with SCI to take without causing too many side effects.

NCT ID: NCT01294397 Terminated - Clinical trials for Rheumatoid Arthritis

Effects of Denosumab on the Pharmacokinetics of Etanercept

Start date: March 2011
Phase: Phase 1
Study type: Interventional

This is a multi-center, open-label, single sequence, denosumab single-dose study in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis (RA) being treated with etanercept.

NCT ID: NCT01166178 Terminated - Multiple Sclerosis Clinical Trials

Zoledronic Acid in MS-patients With Osteoporosis

EXALT
Start date: October 2010
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the efficacy and safety of zoledronic acid 5 mg intravenous (i.v.) relative to placebo in Multiple Sclerosis (MS) patients with osteoporosis and to support the optimal use of zoledronic acid for this indication. Primary objective is the change of Bone Mineral Density (BMD) at lumbar spine (L1-L4) and total hip region assessed by T-Score at month 12 relative to screening as measured by Dual X-ray Absorptiometry (DXA). This double-blind period will be followed by a 52-week open-label treatment phase to assess long-term efficacy and safety of zoledronic acid in these patients.

NCT ID: NCT01159873 Terminated - Osteoporosis Clinical Trials

Single Ascending-Dose Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women

Start date: July 2010
Phase: Phase 1
Study type: Interventional

Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women.

NCT ID: NCT01131884 Terminated - Osteoporosis Clinical Trials

Pilot Study of Fosamax in Spinal Cord Injury

Start date: June 2010
Phase: N/A
Study type: Interventional

Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry (DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months and be required to take oral fosamax versus placebo weekly.

NCT ID: NCT01035177 Terminated - Osteoporosis Clinical Trials

In Vivo Hip Fracture Discrimination With Quantitative Computed Tomography (QCT)

FEMFRACT
Start date: February 2005
Phase: N/A
Study type: Observational

Numerous geometric and bone mineral density (BMD) parameters can be derived from quantitative computed tomography (QCT) images of the proximal femur analyzed using dedicated software. The primary objective is to evaluate the contribution of QCT-image analysis to the prediction of the osteoporotic hip fracture risk, as compared to the reference standard, namely, dual energy X-ray absorptiometry (DXA). Study hypothesis: For predicting osteoporotic hip fracture, findings from QCT images of the proximal femur analyzed using dedicated software are superior over DXA measurements of proximal femoral BMD.