Risedronate in Postmenopausal Women With Low Bone Density

a Six Month, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group Study to Estimate the Pharmacodynamic Response of Two Risedronate Regimens Compared With 5mg Daily : 150mg Monthly Dose for Six Months and 15mg Daily for Thirty Days Followed by 150mg Monthly Dose for 5 Months in Postmenopausal Women With Low Bone Density.

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.

Study Overview

• Status: Completed
• Conditions: OSTEOPOROSIS, POSTMENOPAUSAL
• Intervention / Treatment: Drug: RISEDRONATE

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Urine NTX at week 4 of month 6

Secondary Outcome Measures

Outcome Measure
Urine NTX at other visits, serum CTX and bone specific alkaline phosphatase, lumbar spine BMD

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Procter and Gamble

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): June 1, 2003
• Study Completion (Actual): June 1, 2003

Study Registration Dates

• First Submitted: July 11, 2006
• First Submitted That Met QC Criteria: July 11, 2006
• First Posted (Estimate): July 12, 2006

Study Record Updates

• Last Update Posted (Estimate): February 17, 2012
• Last Update Submitted That Met QC Criteria: February 15, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Risedronic Acid
• Other Study ID Numbers: HMR4003B_2501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No