Clinical trial NCT00351091: Risedronate in Postmenopausal Women With Low Bone Density
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: OSTEOPOROSIS, POSTMENOPAUSAL
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2006-07-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Urine NTX at week 4 of month 6
Secondary outcomes:
measure: Urine NTX at other visits, serum CTX and bone specific alkaline phosphatase, lumbar spine BMD
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: