STAG: effect of the drug AZD4017 on bone density in post-menopausal wome
- Conditions
- OsteoporosisMusculoskeletal DiseasesPostmenopausal osteoporosis
- Registration Number
- ISRCTN32813419
- Lead Sponsor
- niversity of Leeds
- Brief Summary
2020 Abstract results in https://doi.org/10.1530/endoabs.70.AEP130 (added 23/04/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35275196/ (added 07/12/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 55
Current inclusion criteria as of 21/06/2017:
1. Provision of informed consent prior to any study specific procedures
2. Aged >50 and post-menopausal based on amenorrhoea for >12 months
3. Documented presence of osteopenia (BMD T-score at lumbar spine and/or total hip of less than or equal to -1 and greater than -2.5) as measured by DXA
4. Placebo treatment for the duration of the study must not be considered detrimental to the study participant
5. Must be able to understand the patient information sheet and consent form and comply with study requirements
Previous inclusion criteria:
1. Provision of informed consent prior to any study specific procedures
2. Aged >50 and postmenopausal based on amenorrhoea for >12 months
3. Documented presence of osteopaenia (bone density T-score at lumbar spine or hip of less than -1 and greater than -2.5 by Dual-energy X-ray Absorptiometry (DXA) criteria)
4. Placebo treatment for the duration of the study must not be considered detrimental to the study subject
5. Must be able to understand the patient information sheet and consent form and comply with study requirements
Current exclusion criteria as of 21/06/2017:
Bone-related exclusion criteria:
1. Clinical or biochemical evidence of secondary causes of bone loss (screening tests to include but are not restricted to: normal serum sodium, potassium, urea, creatinine (eGFR at >60 mls/min), LFTs, ALP, TFTs; free T4 and TSH), FBC and ESR (<40mm/hr))
2. Vitamin D deficiency (defined as a 25-OH vitamin D level of <20nmol/L)
3. The current or recent use (within the last 2 years) of medication likely to have an impact on bone (oestrogens, aromatase inhibitors, bisphosphonates, fluoride, denosumab, strontium ranelate, anti-convulsants; and oral, inhaled or nasal glucocorticoids). Participants already on calcium/vitamin D supplementation will be asked to continue this for the duration of the study. Those with a 25-OH vitamin D level of 20-50nmol/L at screening will be supplemented prior to inclusion. Medications will be reviewed at the screening visit
4. Bilateral fractures of the radius and/or tibia
General exclusion criteria:
1. Women of child-bearing potential (WOCBP). Note: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea= 12 consecutive months or women on hormone replacement therapy with documented serum follicle stimulating hormone level >35 mIU/mL)
2. Have an estimated glomerular filtration rate (eGFR) calculated by the Modification of Diet in Renal Disease (GFR calculation) using theMDRD equation of <60ml/min/1.73m2
3. Have any endocrine disorder that would merit therapy according to national guidelines. The only exception to this is patients with hypothyroidism on treatment with thyroid function tests within normal parameters for a minimum of 3 months
4. Suspicion of, or known Gilbert's disease
5. CK >2 x ULN on 2 consecutive measurements
6. ALT and/or AST > 1.5*ULN
7. ALP > ULN
8. Bilirubin (total) > 1.5*ULN
9. Participant is, at the time of signing the informed consent, a user of recreational or illicit drugs (including marijuana) or has had a recent history (within the last year) of drug or alcohol abuse or dependence, on questioning or clinical history
10. Have uncontrolled systemic hypertension (BP >150/90) on 3 successive measurements on the morning of the screening visit. Note: Participants with controlled hypertension (BP of 150/90 or better on same treatment for 3 months) may be included, and should continue on the same anti hypertensive medication for the duration of the study. Thus, if hypertension is identified at screening and the hypertension is then treated and remains controlled for 3 months, then the patient may enter screening again
11. Are receiving systemic (including vaginal/rectal) or inhaled glucocorticoid treatment at the time of the screening visit. Note: Topical (skin) application of mild, over-the-counter topical steroid containing medication to small localised areas of the skin is permitted
12. Are taking probenecid at the time of the screening visit
13. Have any screening laboratory abnormality which is outside the local refer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in serum osteocalcin after 90 days.
- Secondary Outcome Measures
Name Time Method <br> 1. Change from baseline in serum ßCTx after 90 days<br> 2. Change in bone density, microstructure and strength after 180 days<br> 3. Change in bone remodelling after 90 days<br> 4. Change in muscle strength after 90 days<br>