Bone mineral density in older people
Conditions
Interventions
Trade Name: Vigantol Oil
Product Name: Vigantol Oil 12,000IU in 2.4mL
Pharmaceutical Form: Oral solution
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Other descriptive name: Cholecalciferol
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ambulant, community dwelling men and women aged 70 years and above 2. Individuals capable of giving informed consent on their own behalf 3. Individuals willing to attend the Study Centre (CARU) on six occasions and to be contacted by telephone at monthly intervals between study visits over twelve months The inclusion criteria are mainly restricted to age and ability to participate in the study. The age cut-off used is the same as the threshold for older age used in the most recently published review and recommendations Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 375
Exclusion criteria
Exclusion criteria: 1. Current antiresorptive or anabolic treatment for osteoporosis 2. Treatment with bisphosphonates for osteoporosis in past two years 3. Current use of vitamin D (>400 IU/day) or calcium (>500 mg/day) (including use of over-the-counter preparations) 4. Fragility fracture in the previous six months 5. Known primary hyperparathyroisism 6. Hypercalcaemia (albumin-adjusted plasma calcium > 2.60 mmol/l) 7. Renal impairment (Stage 4-5 Chronic Kidney Disease: GFR < 30 ml/min/1.73m2) 8. History of renal stones 9. Peanut allergy The exclusion criteria include the presence of a health condition or treatment which is likely to independently affect the outcome measures (criteria: 1, 2, 3, 4, 5, 8) or increase the risk of developing adverse effects with vitamin D supplementation (criteria: 6, 9).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: We aim to establish the effects of three doses of vitamin D supplement, given for 12 months on the change in bone mineral density (BMD) to indicate a beneficial effect on bone health.;Secondary Objective: Secondary Objective: We shall also look at the seasonality and duration of the effects of supplement and blood levels of vitamin D (plasma 25OH Vitamin D concentration) achieved on parathyroid hormone levels and a number of other biochemical markers of bone metabolism, which also give insights into bone health and risk of fracture.;Primary end point(s): The primary outcome measure is the change in BMD at the hip (total hip BMD) as a function of the vitamin D dose, reflecting achieved plasma 25OHD concentration.;Timepoint(s) of evaluation of this end point: This end point will be evaulated at 12 months from baseline for each participant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcome measures are the changes in achieved plasma 250HD concentration and plasma PTH. We will explore their use as functional markers in relation to change in BMD and biochemical markers of bone turnover which will also be collected as further secondary measures. We will also obtain data on the proportion of subjects in each treatment group who fall, the number of falls, quality of life and safety. The bone turnover markers comprise plasma C-terminal telopeptide (CTX), bone specific alkaline phosphatase (bone ALP) and N-terminal propeptide of procollagen type I (P1NP), as it has been suggested that these may be the best surrogate markers for the effect of pharmacological intervention on fracture incidence (Bouxsein, 2008). Data on falls will be collected prospectively using a falls diary, which will be returned to the study centre at each study visit. Quality of life will be assessed using the WHOQOL-OLD & BREF questionnaires; Dietary information will be collected using the validated Calquest dietary calcium intake questionnaire; Overseas travel will be recorded using a sunshine exposure questionnaire. In addition to collecting information on patient-reported adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) through patient questioning and examination, safety will be assessed specifically by performing full blood count, plasma calcium, creatinine and liver function tests at each visit. Information on clinical fractures during the study will be recorded as a safety measure. Samples for measurement of plasma 25OHD, PTH and the biochemical markers of bone turnover and other analyses will be collected at 0, 3, 6, 9 and 12 months .;Timepoint(s) of evaluation of this end point: End of study (12 months) | — |
Countries
United Kingdom
Contacts
Public ContactDr Terence Aspray
Newcastle upon Tyne Hospitals NHS Foundation Trust
Outcome results
None listed