Osteoporosis is a systemic skeletal disorder characterized by low bone mass and micro-architectural deterioration of bone tissue leading to enhanced bone fragility and susceptibility to fracture. Postmenopausal women with a diagnosis of osteopenia (T score between –2.5 and –1.0 based on the World Health Organization classification) may also be at risk of fracture. MedDRA version: 7.0 Level: PT Classification code 10031285
Conditions
Interventions
Trade Name: Actonel Once a Week 35mg film coated tablets
Product Name: Risedronate Sodium 35 mg (Actonel 35 mg)
Product Code: NE-58095
Pharmaceutical Fo
Sponsors
Procter & Gamble Technical Centres Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women meeting all of the following criteria are eligible for randomization into the study: a) ambulatory; b) between 40 and 55 years of age, inclusive; c) cessation of menstruation (surgical or natural) between 6 and 36 months prior to study enrollment and postmenopausal estradiol laboratory values (estradiol or= 30 mIU/mL); d) has osteopenia (as defined in the protocol); e) must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic) f) BMI between 18 and 28 kg/m2, inclusive; g) negative urine (dipstick) pregnancy test (to be done prior to radiation exposure in the screening evaluation); h) in generally good health as determined by medical history, physical examination, and laboratory tests; and i) are willing and able to participate in the study and 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will not be admitted into the study if they exhibit any of the following: a) documented history of illicit drug abuse or alcohol abuse (for the past 2 years); b) evidence of significant psychiatric or organic disease (particularly a history of malignant disease [excluding skin epitheliomas], gastrointestinal, hepatic, renal, or cardiac disease), which, in the opinion of the investigator and the medical monitor, would prevent the patient from completing the study; c) history of tremor disorder; d) history of hyperparathyroidism or recent thyroid disorder; e) history of any generalized bone disease, including hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease, or any known condition that would interfere with the assessment of DXA at either the lumbar spine (or= 20% reduction in anterior-to-posterior or middle-to-posterior height ratio; or >or= 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist; g) glucocorticoid-induced osteopenia; h) previous bisphosphonate therapy; i) use of estrogens and/or progestins for > 1 month at any time within the past 12 months; j) use of any of the following medications for > 1 month at any time within the past 6 months: -corticosteroids or anabolic medications, -calcitonin, -vitamin D (>or= 1000 IU/day), or -diuretics or anticonvulsants; k) use of fluoride (prescribed in the bone therapeutic range of >or=10 mg/day) for > 1 month; l) current use of any of the following medications: -oral or parenteral glucocorticoids, -anabolic steroids, -estrogens (oral, skin patch, gel, or subcutaneous implant), -estrogen-related medications, such as tamoxifene, selective estrogen receptor modulators (raloxifene), tibolone -progestins, -calcitonin, calcitriol, calcifediol, or alfacalcidol -calcium supplements (>500mg/day) -vitamin D supplements (>400 IU/day) -vitamin D depot injection (10,000 IU), -any bisphosphonate (other than the investigational product), -fluoride (>or=10 mg/day), -strontium and other bone active agents (ie isoflavones), -PTH; or -any other investigational product m) history of any allergic or abnormal reaction to bisphosphonates; n) severe renal impairment (creatinine clearance < 30mL/min); o) serum 25-hydroxy vitamin D level < 15 ng/mL; p) markedly abnormal clinical laboratory parameters at screening assessed as clinically significant by the investigator; q) participation in another clinical study 30 days prior to enrollment; r) demonstrated unlikely to comply with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the ability of 3D pQCT to detect a treatment difference with respect to distal radius trabecular bone volume (BV/TV) percent change from Baseline over a 12-month period among osteopenic early postmenopausal women treated with risedronate 35 mg as compared to those treated with placebo.; Secondary Objective: The secondary objectives are to compare the percent change from Baseline between the 2 treatment groups for the following measurements: • BMD of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using dual energy X ray absorptiometry (DXA) scan; • 3D pQCT analysis of distal radius and distal tibia bone microarchitecture data; and • bone turnover markers (BTMs) of fasting serum carboxyterminal cross linking telopeptide of Type 1 bone collagen (CTX 1) and serum aminoterminal propeptide of Type 1 procollagen (PINP). ; Primary end point(s): 3-D-pQCT Data—Microarchitectural Parameters (Distal Radius BV/TV Measurements): The primary efficacy assessment in this study will be BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at Month 12. If there is a history of prior fracture (traumatic or atraumatic) in the non dominant wrist, the dominant wrist will be used. Measurements will be taken using Xtreme CT scanners supplied by SCANCO Medical AG, (Bassersdorf, Switzerland) who will be responsible for the analysis and central reading of the radiological images. The standard procedures and analysis methods for 3D pQCT measurements are described in Appendix 4 of the protocol. | — |
Countries
Germany, United Kingdom
Outcome results
None listed