Risedronate in Postmenopausal Women With Low Bone Density

NCT ID: NCT00351091

Last Updated: 2012-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2003-06-30

Brief 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.

Conditions

OSTEOPOROSIS, POSTMENOPAUSAL

Study Design

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

Interventions

RISEDRONATE

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ambulatory women,postmenopausal >= 5 years
• have lumbar spine baseline BMD within the following criterion :

• Hologic: <= 0.827 g/cm2 or
• Lunar: <= 0.942 g/cm2 or
• Norland: <= 0.768 g/cm2
• be in general good health as determined by medical history, physical examination and laboratory tests

Exclusion Criteria

• serum 25-OH vitamin D level <= 12 ng/ml
• history of osteomalacia
• history of active hyperparathyroidism or hyperthyroidism
• hypocalcemia or hypercalcemia from any cause
• depot injection >10,000 IU Vitamin D in the past 9 months prior to starting the investigational product
• use of Vitamin D supplementation within 3 months prior to starting the investigational product
• use of any of the following medications within a specified number of months prior to starting the investigational product :

• any bisphosphonate.
• use of any fluoride with the exception of fluoride use for oral hygiene
• strontium
• other bone active agents
• subcutaneous estrogen implant
• oral or parenteral glucocorticoids
• anabolic steroids
• estrogen or estrogen-related drugs, except for low dose vaginal creams
• progestogen
• calcitonin, calcitriol, or calcifediol
• any allergic or abnormal reaction to bisphosphonates
• creatinine clearance < 30 ml/min

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

HMR4003B_2501

Identifier Type: -

Identifier Source: org_study_id