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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00351091

Enrollment

150

Registered

2006-07-12

Start date

2002-11-30

Completion date

2003-06-30

Last updated

2012-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OSTEOPOROSIS, POSTMENOPAUSAL

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.

Interventions

DRUGRISEDRONATE

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

65 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Urine NTX at week 4 of month 6	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026