Bone Microarchitecture in Osteopenic Postmenopausal Women

Warner Chilcott

Status and phase

Terminated

Phase 4

Conditions

Osteoporosis

Treatments

Drug: placebo

Drug: risedronate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00577395

2007075

Details and patient eligibility

About

The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.

Enrollment

13 patients

Sex

Female

Ages

40 to 57 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female: 40 and 57 years of age inclusive
cessation of menstruation (surgical or natural) between 12 and 36 months prior to study enrollment
have osteopenia defines as having the following: have osteopenia defined as having the following:
Lumbar spine (L1-L4) Bone Mineral Density (BMD) T score -1 and less than -2.5 AND a total hip T score of greater than -2.5 OR
Lumbar spine (L1-L4) BMD T score greater than -2.5 AND a total hip T score -1 and less than -2.5;
have a body mass index (BMI) between 18 and 30 kg/m2.

Exclusion criteria

history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
hypocalcemia or hypercalcemia of any cause