Osteoporosis Musculoskeletal Diseases Osteoporosis in diseases classified elsewhere
Conditions
Interventions
Randomization to treatment with either:
1. Microgynon 30 ED OC (ethinylestradiol 0.03 mg, levonorgestrel 0.15 mg daily for 21 days with 7 days lactose tablet)
2. Femoston (oestradiol 2 mg daily for 1
Sponsors
The Chinese University of Hong Kong (Hong Kong)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 20-45 years 2. Either 12 months of amenorrhoea or a menstrual cycle of average length 35 days or longer in the previous 12 months 3. At baseline Follicle-stimulating hormone (FSH) > 3.5 IU/L, 2.4 IU/L, < 12.6 IU/L 5. E2 < 201 pmol/L 6. PRL < 496 mIU/L
Exclusion criteria
Exclusion criteria: 1. On exogenous hormones within previous 3 months 2. Any contraindication to the use of female hormones 3. Any condition making it likely that they cannot complete the study 4. Hypergonadotropic or hypogonadotropic hypogonadism or hyperprolactinaemia as defined by abnormal FSH, LH or Prolactin concentrations 5. Any personal or strong family history of breast cancer or endometrial cancer 6. History of pulmonary or venous thromboembolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMD in either spine or femoral neck, measured using dual-energy x-ray absorptiometry (DEXA) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Estimate of bone formation by measurement of serum bone-specific alkaline phosphatase (sBSAP) 2. Estimate of bone resorption by measurement of serum degradation products of C-terminal telopeptides of type 1 collagen (sCTX) 3. Well-being, measured using the Women's Health Questionnaire (WHQ) | — |
Countries
Hong Kong
Outcome results
None listed