A Randomized, Double Blind, Single Centre, study to assess the efficacy, safety and tolerability of the Gastrin Receptor Antagonist (GRA), Netazepide administered for 90 days, in post-menopausal women (OSTEO-GRA)
- Conditions
- Musculoskeletal Diseases
- Registration Number
- PACTR202407466904092
- Lead Sponsor
- niversity of Cape Town
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Female
- Target Recruitment
- 90
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method