A Phase III, Multicenter, Double-Blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly with 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis as Assessed at 12 and 24 Months. 2005032 (EFC6062) (HMR4003K/3001) - MERIT-OP

• Conditions: Osteoporosis in post-menopausal women; MedDRA version: 7.0Level: PTClassification code 10031285

• Registration Number: EUCTR2005-002785-10-HU
• Lead Sponsor: Procter & Gamble Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1068

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified