ISRCTN62937696
Completed
Not 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 enrollmentMarch 1, 2001
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoporosis
- Sponsor
- Action Medical Research (UK)
- Enrollment
- 71
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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