Effect of hormone replacement therapy versus risedronate on fracture recurrence in postmenopausal women with hip fracture

Effect of hormone replacement therapy versus risedronate on fractures recurrence after hip fracture surgery in postmenopausal Korean women: a randomized, open-label trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005513

Enrollment

300

Registered

2020-10-20

Start date

2005-04-07

Completion date

Unknown

Last updated

2020-11-03

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

Conditions

None listed

Interventions

Drug : 1. Drug 1) Estrogen: 17ß-estradiol 1.5 mg (3 pumps)/day, 0.1&#37

percutaneous gel (Estreva gel, Samil Pharm. Co., Seoul, Korea) 2) Progestogne: micronized progesterone 100 mg(1 capsule)/day, per os (Utrogestan, Han Wha Pharma, Co., Seoul, Korea) 3) Risedronate

calcium citrate 950 mg (1 tablet), bid, per os (Calcite, Aju Pharm, Seoul, Korea) 2. Intervention arm 1) Risedronate therapy

risedronate + calcium 2) Hormone therapy

estrogen + progestogen + calcium

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Postmenopausal women (duration of amenorrhea: 12 months or longer or serum follicle-stimulating hormone value: 30 mIU/mL or higher) Acute, first-time, lower-energy trauma hip (femur neck or trochanteric) fracture

Exclusion criteria

Exclusion criteria: Induced menopause due to chemotherapy or radiation Breast cancer Chronic kidney disease Hepatic failure Major abnormalities detected in routine laboratory tests Life expectancy of less than 6 months.

Design outcomes

Primary

Measure	Time frame
Occurrence of any new fracture	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Koo Yoon

Samsung Medical Center

Outcome results