Risedronate in Postmenopausal Women With Low Bone Density

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00351091
First received: July 11, 2006
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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.

Condition Intervention Phase
OSTEOPOROSIS, POSTMENOPAUSAL
Drug: RISEDRONATE
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Urine NTX at week 4 of month 6

Secondary Outcome Measures:
  • Urine NTX at other visits, serum CTX and bone specific alkaline phosphatase, lumbar spine BMD

Enrollment: 150
Study Start Date: November 2002
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351091

Sponsors and Collaborators
Sanofi
Procter and Gamble
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00351091     History of Changes
Other Study ID Numbers: HMR4003B_2501
Study First Received: July 11, 2006
Last Updated: February 15, 2012
Health Authority: Poland: Ministry of Health

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014