Risedronate in Osteopenic Postmenopausal Women

Osteoporosis Clinical Trial

— OSMAUSE  

Official title:

A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography: A 24 Month, Monocenter Study Comparing Weekly Oral Risedronate 35 mg and Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345644
• Other study ID #: HMR4003B_3507
• Secondary ID: EudraCT # :2005-
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2006
• Last updated: December 4, 2009
• Start date: March 2006
• Est. completion date: June 2009

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• risedronate
risedronate sodium 35 mg tablets (once a week dose)
• risedronate placebo
placebo for risedronate tablets (once a week dose)

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Procter and Gamble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Tolerance data :collection of AEs, with special interest for upper gastrointestinal (UGI) AEs and clinical fractures		at all visits	Yes