Circulating Myokine Levels and Bone Metabolism

424 General Military Hospital

Status: Completed

Conditions: Osteoporosis, Postmenopausal

Treatments: Drug: Denosumab; Drug: Teriparatide

Study type: Observational

Funder types: Other

Identifiers

NCT04206618

MYOBONE

Details and patient eligibility

About

Circulating levels of several myokines will be measured in serum samples obtained from women in various categories of bone density and according to the presence of fracture or not as well as before and after treatment with teriparatide and denosumab

Full description

Serum samples for the measurement of several myokines will be obtained from: 1) equal groups of premenopausal women with normal BMD, postmenopausal women with normal BMD, postmenopausal women with osteopenia, and postmenopausal women with osteoporosis; 2) women with hip fracture compared with controls (women subjected to surgery due to knee osteoathritis); 3) women with osteoporosis treated with teriparatide or denosumab for 12 months

Enrollment: 220 patients

Sex: Female

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Substudy 1:

• adult women

Substudy 2:

• postmenopausal women with an incident hip fracture

Substudy 3:

• postmenopausal women with osteoporosis

Exclusion criteria

• secondary osteoporosis
• any disease that could affect muscle and/or bone metabolism
• any medication that could affect muscle and/or bone metabolism

Trial design

220 participants in 8 patient groups

premenopausal normal

Description:

premenopausal women with normal BMD who will be subjected to a single morning, fasting blood drainage

postmenopausal normal

Description:

postmenopausal women with normal BMD who will be subjected to a single morning, fasting blood drainage

postmenopausal osteopenia

Description:

postmenopausal women with osteopenia who will be subjected to a single morning, fasting blood drainage

postmenopausal osteoporosis

Description:

postmenopausal women with osteoporosis who will be subjected to a single morning, fasting blood drainage

hip fracture

Description:

postmenopausal women at the moment of hip fracture who will be subjected to a single, fasting blood drainage right before osteosynthesis

controls (knee osteoarthitis)

Description:

postmenopausal women with knee osteoarthritis who will be subjected to a single, fasting blood drainage right before arthroplasty and serve as controls

teriparatide group

Description:

postmenopausal women with osteoporosis who will be treated with teriparatide (Forsteo) 1 injection of 20mcg subcutaneously daily for 12 months

Treatment:

Drug: Teriparatide

denosumab group

Description:

postmenopausal women with osteoporosis who will be treated with denosumab (Prolia) 1 injection of 60mg subcutaneously every 6 months for 12 months

Treatment:

Drug: Denosumab