ISRCTN62937696CompletedNot Applicable
A randomised controlled trial of combination therapy using calcium/vitamin D and protein/calorie supplements in nutritionally deficient women: an assessment of changes in osteoporotic fracture risk
Action Medical Research (UK)0 sites71 target enrollmentStarted: March 1, 2001Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 71
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1. Women over 70 years
- •2. Body mass index of less than 21 kg/m^2
- •3. Osteoporosis at the femoral neck and/or total hip
Exclusion Criteria
- •1. Evidence of any progressive wasting disease, e.g. carcinomatosis, severe malabsorption
- •2. Severe renal impairment (estimated glomerular filtration rate [GFR] less than or equal to 45 ml/min)
- •3. Severe cardiorespiratory diseases
- •4. Endocrine diseases, e.g., hyperparathyroidism, hyperthyroidism
- •5. Therapy with drugs known to interfere with bone metabolism such as steroids, vitamin D or its derivatives, bisphosphonates, oestrogen, raloxifene
- •6. Cognitive impairment (abbreviated mental test score 7 or below)
Investigators
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