A Randomised Control Trial to Compare the Effects of Hydroxyapatite Preparations, Calcium Citrate and Calcium Carbonate on Serum Calcium and Markers of Bone Turnover in Healthy Postmenopausal Women.

Completed

• Conditions: Osteoporosis; Vascular disease; Metabolic and Endocrine - Other metabolic disorders; Musculoskeletal - Osteoporosis; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12611000232932
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Female, postmenopausal 5 years or more (menopause defined as at least 12 months since last period in a woman aged > 45 yrs with intact uterus, or serum oestradiol < 100 pmol/l with FSH > 50 IU/l in younger or hysterectomised woman).

Exclusion Criteria

Past history of coronary heart disease, cerebrovascular disease or peripheral vascular disease, estimated 5-year cardiovascular risk >15%, renal impairment (serum creatinine >0.15 mmol/L), chronic liver disease, untreated hypothyroidism or hyperthyroidism, concurrent major systemic illness (including malignancy), active major gastrointestinal disease, metabolic bone diseases, or serum ALP >normal, primary hyperparathyroidism, current or expected use of oral glucocorticoid drugs during the trial period, current or past use of bisphosphonate therapy in the preceding 2 years, use of hormone replacement therapy within the last 12 months, use of other medication known to cause osteoporosis or interfere with bone metabolism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in serum calcium (total and ionised) following the first supplement dose at baseline.[0, 2, 4, 6 and 8 hours after the first supplement dose at baseline. 20% of participants will have serum calcium measurements repeated at week 12 following their final supplement dose.];Change in markers of bone turnover (PINP, parathyroid hormone and beta-C-telopeptide) will be measured by plasma and serum analysis.[Baseline and 12 weeks from baseline]

Secondary Outcome Measures

Name	Time	Method
Changes in indices of blood coagulation following the first supplement dose at baseline will be measured by thromboelastography.[0, 2, 4, 6 and 8 hours after the first supplement dose at baseline.];Changes in indices of vascular function (fetuin A, others to be confirmed) will be measured by plasma and serum analysis.[Baseline and 12 weeks from baseline.]