Condition category
Musculoskeletal Diseases
Date applied
01/03/2001
Date assigned
01/03/2001
Last edited
12/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Geeta Hampson

ORCID ID

Contact details

Senior Lecturer
Department of Chemical Pathology
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 (0)20 7928 9292 ext 2881
geeta.hampson@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AP0714

Study information

Scientific title

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

Acronym

Study hypothesis

To investigate the effects of dietary advice and nutritional supplementation on bone mineral density.

Ethics approval

The Research Ethics Committee of the Guy’s and St Thomas’ Hospital NHS Trust gave approval

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Osteoporosis

Intervention

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 supplements to increase their dietary intake and calcium/vitamin D

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Body composition and bone mineral density (BMD), assessed at baseline and 12 months.

Secondary outcome measures

Biochemical markers of bone turnover, measured at baseline and at 1, 3, 6, 9 and 12 months.

Overall trial start date

01/09/1999

Overall trial end date

31/08/2001

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

71

Participant 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)

Recruitment start date

01/09/1999

Recruitment end date

31/08/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Senior Lecturer
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Action Medical Research (UK)

Sponsor details

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Sponsor type

Charity

Website

http://www.action.org.uk/

Funders

Funder type

Charity

Funder name

Action Medical Research (UK)

Alternative name(s)

AMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12904840

Publication citations

  1. Results

    Hampson G, Martin FC, Moffat K, Vaja S, Sankaralingam S, Cheung J, Blake GM, Fogelman I, Effects of dietary improvement on bone metabolism in elderly underweight women with osteoporosis: a randomised controlled trial., Osteoporos Int, 2003, 14, 9, 750-756, doi: 10.1007/s00198-003-1440-1.

Additional files

Editorial Notes