OSMAUSE: Risedronate in Osteopenic Postmenopausal Women

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00345644

Collaborator

Procter and Gamble (Industry)

156

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: risedronate Drug: risedronate placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: risedronate risedronate sodium 35 mg tablets (once a week dose)
Placebo Comparator: 2	Drug: risedronate placebo placebo for risedronate tablets (once a week dose)

Arm

Intervention/Treatment

Experimental: 1

Drug: risedronate

risedronate sodium 35 mg tablets (once a week dose)

Placebo Comparator: 2

Drug: risedronate placebo

placebo for risedronate tablets (once a week dose)

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Paris		France

Sponsors and Collaborators

Sanofi
Procter and Gamble

Investigators

Study Director: Marie SEBILLE, Dr, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00345644

Other Study ID Numbers:

HMR4003B_3507
EudraCT # :2005-005598-30

First Posted:

Jun 28, 2006

Last Update Posted:

Dec 7, 2009

Last Verified:

Dec 1, 2009

Keywords provided by , ,

Postmenopausal

Additional relevant MeSH terms:

Osteoporosis

Risedronic Acid

Etidronic Acid

Study Results

No Results Posted as of Dec 7, 2009