Musculoskeletal Diseases
Conditions
Interventions
Placebo
Sponsors
University of Cape Town
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: A participant must meet the following criteria to be eligible for inclusion in the study: 1. Women >5 years post-menopausal or who have had an oophorectomy 2. FSH levels of >40 IU/L (the FSH level precludes premenopausal women and those who may have FSH-related bone losses) as determined at the screening visit. 3. Participants with no clinical or biochemical evidence of secondary causes of bone loss (Appendix 1). 4. Participants must not be taking medications (see Appendix 6) that have an action on bone metabolism
Exclusion criteria
Exclusion criteria: A participant who meets any of the following criteria will be excluded from the study: 1. Participants with confirmed diagnoses according to their medical history from diseases with a known propensity to result in secondary bone loss that might cloud the assessment of disease naïve osteoporosis. It includes Diabetes Mellitus, thyroid dysfunction (TSH outside the reference range), IBD, celiac disease, pancreatic exocrine insufficiency, epilepsy, hyperparathyroidism. (Appendix 1) 2. Participants who have had a bone fracture in the previous year. (Appendix 1) 3. Participants who have had orthopaedic surgery in the previous year. (Appendix 1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CTX levels in post-menopausal women before and after GRA administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone resorption: NTX (urine) and serum TRAP levels;Individual biomarkers PINP, Osteocalcin and Alk Phos ;Bone balance: To determine whether the GRA has an effect on bone balance, we will calculate the ratio of CTX/PINP at baseline and each of the 4 follow-up time points | — |
Countries
South Africa
Contacts
Public ContactStuart More
Principal Investigator
Outcome results
None listed