Risedronate in Osteopenic Postmenopausal Women

Phase 3

Completed

• Conditions: Osteoporosis
• Interventions: Drug: risedronate; Drug: risedronate placebo

• Registration Number: NCT00345644
• Lead Sponsor: Sanofi

Brief Summary

The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative computed tomography (3D pQCT).

The secondary objectives are to compare the percent change from Screening/Baseline between the 2 treatment groups for the following measurements:

* Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months;

* 3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 months; and

* Bone turnover markers (BTMs) of:

* fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen (CTX 1);

* serum aminoterminal propeptide of type 1 procollagen (PINP); and

* urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-20
• Study First Submitted QC: 2006-06-27
• Study First Posted: 2006-06-28
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

Inclusion Criteria

• Osteopenic, postmenopausal women, between 55 and 75 years of age with a body mass index (BMI) < 30 kg/m²

Exclusion Criteria

• Clinical or radiological evidence of osteoporosis
• Severe renal impairment
• Serum 5-hydroxy vitamin D level < 15 ng/ml
• History of recent primary hyperparathyroidism or recent thyroid disorder
• History of any generalized bone disease
• Current use of glucocorticoids, estrogens, progestins, calcium supplements > 1 g/day, vitamin D supplements > 800 IU/day, parathyroid hormone (PTH), or any bisphosphonate for > 1 month at any time within the past 6 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	risedronate	-
2	risedronate placebo	-

Primary Outcome Measures

Name	Time	Method
Efficacy data : 3-D-pQCT Data-Microarchitectural Parameters (Distal Radius BV/TV Measurements)	BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at Month 12

Secondary Outcome Measures

Name	Time	Method
Tolerance data :collection of AEs, with special interest for upper gastrointestinal (UGI) AEs and clinical fractures	at all visits

Trial Locations

Locations (1)

Sanofi-Aventis; 🇫🇷 Paris, France