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Multicenter randomized controlled trial of low-dose hormone replacement therapy for low bone density in early postmenopause females

Multicenter randomized controlled trial of low-dose hormone replacement therapy for low bone density in early postmenopause females

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16008202
Enrollment
Unknown
Registered
2016-04-01
Start date
2016-05-05
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

menopause

Interventions

standard dose group:hormone replacement
low-dose group:low-dose hormone replacement

Sponsors

Shannghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) 40~55 years and natural menopause more than 1 year; (2) bone mineral density in waist or hip is lower than the peak bone mass of 1.0SD (3) without anti osteoporosis drugs (not including calcium and VitD activity) in the past 3 months ; (4) with bone pains; (5) willing to comply with the clinical trial and regular follow up; (6) understand the content of the study, signed informed consent; (7) no pregnancy; (8) no severe liver and kidney disease; (9) no contraindications for hormone treatment, such as breast cancer and endometrial cancer; (10) over the past 12 months without taking hormone replacement therapy.

Exclusion criteria

Exclusion criteria: (1) taking estrogen or other steroid hormones in recent 12 months; (2) in patients with malignant tumors (3) severe mental disorders without follow-up; (4) cooperation can not understand the research contents and signed informed consent; (5) pregnancy or planned pregnancy, not included in the study after oral contraceptives; (6) severe neurological dysfunction,and not take care of themselves; (7) expected survival of <3 years with other diseases; (8) included in other studies, and the conflict between studies; (9) hypertension, hyperglycemia and hyperlipidemia, cardiovascular disease, ovarian disorders were excluded; (10) with lumbar disc herniation, ankylosing spondylitis, pain disease caused by spinal spondylolisthesis; (11) secondary osteoporosis, taking drugs affecting bone metabolism, or more than two fractures; (12) hyperparathyroidism, hyperthyroidism, liver and kidney dysfunction, serious cardiovascular and cerebrovascular diseases, who can not move.

Design outcomes

Primary

MeasureTime frame
bone mineral density;

Secondary

MeasureTime frame
fracture;

Countries

China

Contacts

Public ContactTao Minfang

Shanghai Sixth People's Hospital

taomf@126.com+86 18930177770

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026