A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography: A 12 Month, Multicenter, Double-blind, Randomized, Parallel Group Study Comparing Weekly Oral Risedronate 35 mg and Placebo

Procter & Gamble Technical Centres Limited0 sites156 target enrollmentDecember 2, 2005

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: 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.
Sponsor: Procter & Gamble Technical Centres Limited
Enrollment: 156
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

December 2, 2005

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Procter & Gamble Technical Centres Limited

•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.

•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 (
•f) clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (\>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;