Status:
RECRUITING
The MUSE Study for Menopausal Arthralgia
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Arthralgia
Menopause
Eligibility:
FEMALE
30-59 years
Phase:
PHASE2
PHASE3
Brief Summary
The investigators plan to conduct a pilot 4-arm, randomized study comprising the following interventions: muscle strengthening exercises (MSE) alone, estrogen therapy (ET) alone, and a combination of ...
Detailed Description
Recruited participants will be randomized to one of the following arms for 12 weeks: usual clinical care, 17b-Estradiol/progesterone (ET) only, Muscle strengthening exercises (MSE) only, combination o...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients with muscle stiffness and joint discomfort in various sites, including hands, knees, back, hips, and/or shoulders. Patients with pain in only one isolated joint would not be accepted.
- Arthralgia symptoms with onset, or has become worse, over the perimenopausal or early postmenopausal period (within 5 years of the menopause).
- Women should be at the menopause transition, less than or equal to 59 years old at the time of enrollment, or within 5 years of menopause whichever is earlier.
- .
- Arthralgia for at least 3 months (pain lasting beyond normal injury healing period)
- Community-dwelling and able to ambulate independently.
- EXCLUSION CRITERIA:
- History of thrombo-embolic diseases, strokes, ischemic heart disease, dementia or psychiatric disorders, active liver disease or renal impairment, severe hyperlipidemia, gout, thyroid disease, systemic lupus erythematosus, rheumatoid arthritis, or other chronic inflammatory conditions.
- Pregnancy
- Non-adherence to national guidelines for breast cancer screening
- High risk for breast cancer
- Any joint surgery within the last 6 months
- Severe obesity: BMI\>35
- Migraine with aura
- Poorly controlled diabetes
- Use of any form of female hormone supplementation within the past 12 weeks.
- High venous thromboembolism risk
- Current cholecystitis, fibroids, or undiagnosed abnormal uterine bleeding.
- Current smoker.
- History of endometrial, ovarian, peritoneal, cervical, breast or endocrine-dependent cancers.
- Receiving treatment for any form of cancer.
- History of fragility bone fractures within the 2 years.
- Any other cognitive, musculoskeletal, neurological, and cardiorespiratory condition affecting one's ability to participate in the study.
Exclusion
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06530459
Start Date
August 1 2024
End Date
April 1 2028
Last Update
July 31 2024
Active Locations (1)
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1
National University Hospital
Singapore, Singapore