Risedronate in Postmenopausal Women With Low Bone Density

Status Completed

Clinical Trial Summary

The primary objective of this pilot study is to estimate the percent change from baseline at Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment period both compared to a 5 mg daily dose of risedronate for 6 months

The secondary objectives are :

- To estimate the percent change from baseline at specified visits other than Week 4, Month 6 in NTX for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate.

- To estimate the percent change from baseline at all specified visits in serum CTX and bone specific alkaline phosphatase for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily of risedronate.

- To estimate the percent change from baseline at Month 6 in lumbar spine BMD for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate.

- To evaluate the safety of the risedronate 150 mg monthly and the loading dose regimen.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

OSTEOPOROSIS, POSTMENOPAUSAL

Clinical Trial Details

NCT number	NCT00351091
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 2
Start date	November 2002
Completion date	June 2003

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03931109` - Circulating miRNA in Primary Hyperparathyroidism
Not yet recruiting	`NCT03232476` - Effect of Mechanical Loading With PTH on Cortical Bone	Phase 4
Completed	`NCT02884401` - Peri-implant Bone Changes in Post-menopausal Osteoporotic Women	N/A
Completed	`NCT00073190` - Patient- and Physician-Based Osteoporosis Education	Phase 1
Completed	`NCT00402441` - Risedronate in the Prevention of Osteoporosis in Postmenopausal Women	Phase 4
Completed	`NCT03710889` - Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption	Phase 3
Completed	`NCT00010712` - Effects of Black Cohosh on Menopausal Hot Flashes	Phase 2
Recruiting	`NCT05058976` - Romosozumab Use to Build Skeletal Integrity	Phase 4
Recruiting	`NCT05405894` - Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Recruiting	`NCT03337971` - Nutritional Supplement and Bone Health in Post-Menopausal Women	N/A
Completed	`NCT03701113` - Milk Protein and Bone Health in Postmenopausal Women	N/A
Completed	`NCT01381588` - The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women	N/A
Completed	`NCT00383422` - Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis	Phase 3
Completed	`NCT00549965` - Satisfaction and Compliance of Risedronate in PMO	Phase 4
Completed	`NCT00035256` - Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis	Phase 4
Completed	`NCT01386281` - Julina Post-marketing Surveillance for Climacteric Symptoms in Japan
Completed	`NCT05266261` - Use of Ibandronate in Diabetic Patients	N/A
Recruiting	`NCT04964388` - Effect of GLP-1 Receptor Agonists on Trabecular Bone Score	Phase 2
Active, not recruiting	`NCT03623633` - Comparative Antiresorptive Efficacy Discontinuation of Denosumab	Phase 4
Recruiting	`NCT05575167` - Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)