Clinical trial of the Estrogen replacement effect on Physical Performance to muscle resistance exercise for elderly with Osteoarthritis of Knee joint.

A randomized, placebo-controlled, double-blinded clinical trial of the Estrogen replacement effect on Physical Performance to muscle resistance exercise for elderly with Osteoarthritis of Knee joint. - The EPOK Trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061210062

Enrollment

Registered

2021-12-17

Start date

2022-08-04

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

knee osteroarthritis knee osteoarthritis

Interventions

Transdermal administration of Estradiol

D015914

Estrogen replacement therapy

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: For those that meet all the following criteria. (1) The person that a document agreement was provided after enough understanding and have been received enough explanation on participating of this study. (2) A person who is 65 years of age or older when obtaining consent. (3) A person who has osteoarthritis with knee pain at least 3 months (4) A person who can walk themselves without any help.

Exclusion criteria

Exclusion criteria: For those meet one of the following exclusion criteria. (1) Those who are diagnosed following disease or condition having difficult to perform exercise. Cardiovascular disease, Cerebral palsy, Home oxygen therapy, Mental illness (2) History of lower limb bone fracture within 2 years,upper limb bone fracture within 6 months. (3) those who are bedridden condition for more than 1 week within 2 months, or bedridden condition for more than 2 weeks within 6 months (4) Those who have difficulty ingesting (5) History of Endometrial cancer, Ovarian cancer, Peritoreal cancer, Cervical cancer within 5 years. (6) History of Breast cancer within 5 years. (7) Those who have severe liver function disorder

Design outcomes

Primary

Measure	Time frame
Compare the degree of lower limb physical performance. The most important evaluation factor is Chair stand test-30sec ( The arms are to be crossed at the wrists and held close to the chest. From the sitting position, the subject stands completely up, then completely back down, and this is repeated for 30 seconds.) The measurement has to be done once before intervention and twice after intervention(3month, 12month after)	—

Measure

Time frame

Compare the degree of lower limb physical performance. The most important evaluation factor is Chair stand test-30sec ( The arms are to be crossed at the wrists and held close to the chest. From the sitting position, the subject stands completely up, then completely back down, and this is repeated for 30 seconds.) The measurement has to be done once before intervention and twice after intervention(3month, 12month after)

—

Secondary

Measure	Time frame
1) Knee pain score: Visual Analogue 2) Muscle Strength: 3) Muscle Mass: Total Lean Mass, Skeletal Muscle Index 4) Physical Performance: Gait speed,Timed up and go 5) Blood Sample 6) Quality of Life: Short Form Health Survey -12	—

Contacts

Public ContactTOMOHIRO MITOMA

OKAYAMA University Hospital

tomohiro.mitoma@gmail.com+81-86-235-7320

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026