Risedronate in Postmenopausal Women With Low Bone Density

OSTEOPOROSIS, POSTMENOPAUSAL Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351091
• Other study ID #: HMR4003B_2501
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2006
• Last updated: February 15, 2012
• Start date: November 2002
• Est. completion date: June 2003

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• OSTEOPOROSIS, POSTMENOPAUSAL

Intervention

Drug:
• RISEDRONATE

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Procter and Gamble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine NTX at week 4 of month 6
Secondary	Urine NTX at other visits, serum CTX and bone specific alkaline phosphatase, lumbar spine BMD