Risedronate in Osteopenic Postmenopausal Women

NCT ID: NCT00345644

Last Updated: 2009-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-06-30

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

risedronate

Intervention Type: DRUG

risedronate sodium 35 mg tablets (once a week dose)

2

Group Type: PLACEBO_COMPARATOR

risedronate placebo

Intervention Type: DRUG

placebo for risedronate tablets (once a week dose)

Interventions

risedronate

risedronate sodium 35 mg tablets (once a week dose)

Intervention Type: DRUG

risedronate placebo

placebo for risedronate tablets (once a week dose)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Marie SEBILLE, Dr

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Paris, , France

Countries

France

Other Identifiers

EudraCT # :2005-005598-30

Identifier Type: -

Identifier Source: secondary_id

HMR4003B_3507

Identifier Type: -

Identifier Source: org_study_id