Risedronate 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.

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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

65 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

risedronate

Drug

Primary outcomes

Urine NTX at week 4 of month 6

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

Procter and Gamble

Registry information

Official study 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.

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Jul 12, 2006
Registry last updated: Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed