A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy from Alendronate to Denosumab AMG 162 in Postmenopausal Women with Low Bone Mineral Density - STAND
- Conditions
- Postmenopausal Women with Low Bone Mineral DensityMedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal
- Registration Number
- EUCTR2006-000849-19-IT
- Lead Sponsor
- AMGEN S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 500
Ambulatory postmenopausal women, with BMD g/cm2 values that correspond to a T-score 8804; -2.0 and 8805;-4.0 at the lumbar spine or total hip. Subjects must have received alendronate treatment of 70 mg/wk or equivalent for at least 6 months prior to screening.
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
unstable hyper or hypothyroidism; hypo or hyperparathyroidism; epatic or renal impairment; hypo or hypercalcemia; acute gastric or duodenal ulcer or history of gastrointestinal bleed; reumatoid arthritis, Paget s disease, Cushing s disease, cirrhosis of the liver, hyperprolactinemia, positive test for HIV, hepatitis C or B, malignancies within the last 5 years, malabsorption syndrome.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method