Osteoporosis in post-menopausal women MedDRA version: 7.0 Level: PT Classification code 10031285
Conditions
Interventions
Product Name: Risedronate sodium 150 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: risedronic acid
CAS Number: 115436-72-1
Current Sponsor code: NE-58095
Concentration unit: mg milli
Sponsors
Procter & Gamble Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) be female, ambulatory, and 50 years of age or older; b) be in generally good health; c) be postmenopausal (= 5 years since last menses, natural or surgical); d) have at least 3 evaluable lumbar spine vertebral bodies (L1-L4), namely without fracture or degenerative disease; e) meet one of the following lumbar spine BMD criteria: • have lumbar spine BMD (L1-L4) less than 0.772 g/cm2 (Hologic) or 0.880 g/cm2 (Lunar), corresponding to a BMD more than 2.5 SD below the young adult female mean value, or • have lumbar spine BMD (L1-L4) less than 0.827 g/cm2 (Hologic) or 0.940 g/cm2 (Lunar), corresponding to a BMD more than 2.0 SD below the young adult female mean value, and at least one prevalent vertebral body fracture (T4-L4); f) be willing and able to provide 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: a) any previous or ongoing clinically significant illness b) abuse of alcohol, c) abuse of prescription or illicit drugs, d) any condition or disease that may interfere with the evaluation of lumbar spine BMD as determined in a Screening radiograph by a radiologist at the central e) bilateral hip prostheses; f) history of hyperparathyroidism, g) uncontrolled hyperthyroidism or ongoing osteomalacia at the time of enrollment; h) any history of cancer within past 5 years, except for basal cell carcinoma and dermalsquamous cell carcinoma with documented 6-month remission. Patients with a recent history of successfully treated cervical carcinoma in situ will not be excluded provided there is documented 12-month remission; i) a Body Mass Index > 32 kg/m2; j) any known allergic or abnormal reaction to bisphosphonates; k) use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug: • oral glucocorticoids = 5 mg prednisone or equivalent/day; • anabolic steroids • estrogens except for low dose vaginal creams, tablets or insertable estrogen ring • progestins • calcitonin • vitamin D supplements (> 1000 IU per day) • calcitriol, calcidiol, or alfacalcidol at any dose • any bisphosphonate • fluoride (= 10 mg/day) • strontium (= 50 mg/day) • PTH • products in the phytoestrogen or isoflavone classes l) depot injection > 12,000 IU vitamin D in the past 9 months; m) markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the Investigator (Appendix 1); n) creatinine clearance of < 30 mL/min, o) hypocalcemia or hypercalcemia from any cause; p) serum thyroid stimulating hormone (TSH) value outside the permissible range of 0.38-9.99 mU/L. ( q) serum 25-hydroxy vitamin D level < 12 ng/mL (30 nmol/L); r) participation in another clinical trial 30 days prior to Screening; s) demonstrated poor likelihood of completing the study and complying with protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Percentage change from Baseline in lumbar spine BMD at 12 months in women with postmenopausal osteoporosis.;Main Objective: The primary objective is to study the efficacy of a single-dose monthly dosing regimen (150 mg monthly, referred to in this protocol as the Monthly Regimen) of risedronate, compared to the standard daily dosing regimen (5 mg daily, referred to in this protocol as the Daily Regimen) of risedronate, in order to assess the non-inferiority of the Monthly Regimen to the Daily Regimen, as determined by the percentage change from Baseline in lumbar spine BMD at 12 months in women with postmenopausal osteoporosis.;Secondary Objective: • change from Baseline in lumbar spine BMD at Month 12 • change and percentage change from Baseline in lumbar spine BMD at Months 6, 24, and endpoint • percentage of responders at Months 12 and 24 • change and percentage change from Baseline in BMD of the total proximal femur, femoralneck, and trochanter at Months 6, 12, 24, and endpoint • change and percentage change from Baseline in bone resorption and bone formation markers at Months 3, 6, 12, 24, and endpoint • number of patients with at least one new vertebral body fracture at Months 12, 24, and endpoint • change from Baseline in patient-reported outcomes at Months 12 and 24. | — |
Countries
Belgium, Estonia, Finland, Hungary, Spain
Outcome results
None listed