Treatment of Post-menopuasal Osteoporosis MedDRA version: 9.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal
Conditions
Interventions
Product Name: risedronate sodium 35 mg tablets
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: risedronic acid
CAS Number: 115436-72-1
Current Sponsor code: NE-58095
Other descriptiv
Sponsors
Procter & Gamble Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: female, ambulatory and 50 years of age or older in good health as determined by the investigator be postmenopausal(>=5 years since last menses) FSH and estradiol levels are evaluated for any patient =40 mIU/ml and estradiol 2.5SD below young adult mean OR lumbar spine BMD 2.0SD below young adult mean and at least one prevalent vertebral fracture written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: previous or ongoing clinically significant illness abuse of alcohol, prescription or illicit drugs any condition or disease that may interfere with evaluation of lumbar spine BMD bilateral hip prostheses hyperparathyroidism unless sugically corrected and normal serum calcium levels 12 months prior to enrollment uncontrolled hyperthyroidism or ongoing osteomalacia history of cancer in last 5 years except basal cell carcinoma and dermal squamous cell carcinoma with 6-month remission BMI >32 kg/m2 known allergy or intolerance to bisphosphonates or any of the excipients use of IV bisphosphonates within 12 months any use of following medications within 3 months of study, or use greater than 1 month 3-6 months prior to study: anabolic steroids, estrogens (except low dose), progestins, calcitonin, vit D supplements (>1200 IU per day), calcitriol, calcidiol or alfacalcidol, bisphosphonates, fluoride >=10mg daily, PTH and teriperatide, glucocorticoid use as defined in the protocol and a depot injection of vit D >12,000 IU in the past 9 months abnormal clinical laboratory results, including creatinine clearance, hypocalcaemia, hypercalcaemia, TSH and serum 25-hydroxy vitamin D as defined in the protocol participation in another clinical trial 30 days prior to screening BMD =50 mg/day) within 6 months prior to the first dose of study drug or for more than 3 months at any time in the past 10 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the non-inferiority of risedronate, administered as a 35mg DR weekly regimen administered immediately following breakfast, compared to the 5mg IR daily regimen administered at least 30 minutes before breakfast as determined by % change from baseline in lumbar spine BMD at Week 52. If, and only if the weekly regimen is non-inferior to the daily regimen, assess the non-inferiority of the 35mg DR weekly risedronate formulation, administered at least 30 minutes before breakfast, compared to the 5mg IR daily risedronate formulation, administered at least 30 minutes before breakfast, as assessed by % change from baseline in lumbar spine BMD at Week 52;Secondary Objective: Evaluate efficacy of the DR regimens in change from baseline in lumbar spine BMD at Week 52 Evaluate efficacy of the DR regimens by change and % change from baseline in lumbar spine BMD at Weeks 26, 52 and 104 If both DR weekly regimens are non-inferior to the 5mg IR daily regimen as above, the pooled DR results will be assessed on % change from baseline in lumbar spine BMD at Week 52 to show superiority of the DR weekly regimen Evaluate efficacy of the DR regimens by change and % change from baseline in BMD of total proximal femur, femoral neck and greater trochanter at Week 26, 52 and 104 Evaluate efficacy of the DR regimens by change and % change from baseline in BTMs (CTX, NTX, BAP) at Weeks 13, 26, 52 and 104 Determine the % of responders (patients who show a postive change [>0g/cm2]in lumbar spine BMD ar Week 52 and 104 Determine the % of patients with at least 1 new vertebral body fracture at Week 52 and 104;Primary end point(s): The % change from baseline in lumbar spine BMD at Week 52 | — |
Countries
Belgium, Estonia, France, Hungary, Poland
Outcome results
None listed