Postmenopausal osteoporosis MedDRA version: 7.0 Level: PT Classification code 10031285
Conditions
Interventions
Product Name: risedronate 75mg
Product Code: NA
Pharmaceutical Form: Film-coated tablet
Trade Name: Actonel 5mg Film-coated tablets
Pro
Sponsors
Procter & Gamble Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female, ambulatory, age 50 years and older - Postmenopausal > or = 5 years without menses (natural or surgical). FSH and estradiol will be evaluated for any subject =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any previous or ongoing clinically significant illness that, in the opinion of the investigator, could prevent the subject from completing the study; - Abuse of alcohol - Abuse of prescription or illicit drugs - Any condition or disease which may interfere with the evaluation of lumbar spine BMD - History of hyperparathyroidism, unless surgically corrected at least 12 months prior to enrollment. - Ongoing hyperthyroidism or osteomalacia at the time of enrollment - Any history of cancer within past 5 years, except for dermal squamous and basal cell carcinoma with documented 6 month remission. Subjects with a more recent history of successfully treated cervical carcinoma in situ will not be excluded provided there is documented 12 month remission. - BMI > 32kg/m2 - Any allergic or abnormal reaction to bisphosphonates - Use of any of the following medications within 3 months of starting investigational product or use of any of the following medications for more than 1 month at any time within 6 months prior to starting investigational product: a) Oral or parenteral glucocorticoids (> or = 5mg prednisone or equivalent/day); b) Anabolic steroids; c) Estrogens (oral, skin patch or gel), SERMs (raloxifene) or estrogen-related drugs eg tamoxifen, tibolone, except for low dose vaginal creams, tablets or insertable estrogen ring (800 IU per day) g) Calcitriol, calcidiol, or alfacalcidol at any dose h) any bisphosphonate i) Fluoride (> or = 10 mg/day) j) Strontium and other bone active agents (isoflavones) k) Parathyroid hormone - Depot injection >10,000 IU vitamin D in the past 9 months - Markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator - Creatinine clearance of < 30mL/min - Hypocalcemia or hypercalcemia from any cause - Serum TSH value outside the normal laboratory range - Serum 25-hydroxy Vit D level <12ng/Ml (30nmol/L) - Participation in another clinical trial 30 days prior to enrollment - Demonstrated unlikely to comply with protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Demonstrating the non-inferiority of the two-consecutive day, monthly regimen to the daily regimen assessed by percent change from baseline in lumbar spine bone mineral density (BMD) at 12 months in women with postmenopausal osteoporosis (PMO).;Main Objective: To determine the efficacy of a two-consecutive-day, monthly dosing regimen (75mg on two consecutive days, monthly) of risedronate compared to a daily dosing regimen (5mg daily) of risedronate, by demonstrating the non-inferiority of the two-consecutive day, monthly regimen to the daily regimen assessed by percent change from baseline in lumbar spine bone mineral density (BMD) at 12 months in women with postmenopausal osteoporosis (PMO).; Secondary Objective: - % change from baseline in lumbar spine BMD at months 6 and 24. - % of responders in lumbar spine BMD) at months 12 and 24. - % change from baseline in total proximal femur, femoral neck, and trochanter BMD at months 6, 12 and 24. - % Change from baseline in urine NTX and serum BAP at months 3, 6, 12 and 24 in all subjects. - Number of subjects with at least one new vertebral body fracture at months 12 and 24. - Change from baseline in patient reported outcomes at months 12 and 24. - Safety of the 2-day monthly regimen of risedronate, compared to the daily regimen using: assessment of clinical laboratory values, vital signs, clinical fractures, adverse event profiles, and bone histomorphometry. | — |
Countries
United Kingdom
Outcome results
None listed