Osteoporosis Musculoskeletal Diseases Osteoporosis
Conditions
Interventions
Women meeting the entry criteria will be randomised to one of two groups:
1. A control group will receive calcium/vitamin D only
2. The second group will receive dietary advice and nutritional supplem
Sponsors
Action Medical Research (UK)
Eligibility
Sex/Gender
Female
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body composition and bone mineral density (BMD), assessed at baseline and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical markers of bone turnover, measured at baseline and at 1, 3, 6, 9 and 12 months. | — |
Countries
United Kingdom
Outcome results
None listed