Osteoporosis, Postmenopausal
Conditions
Brief summary
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
Detailed 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
Interventions
DRUGTeriparatide
1 subcutaneous injection daily for 12 months
DRUGDenosumab
1 subcutaneous injection every 6 months for 12 months
Sponsors
Beth Israel Deaconess Medical Center
424 General Military Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| follistatin | 0,3,12 months | circulating levels of myokine follistatin at baseline and their changes at 3 and 12 months with treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| activin-A | 0,3,12 months | circulating levels of myokine activin-A at baseline and their changes at 3 and 12 months with treatment |
| FSTL3 | 0,3,12 months | circulating levels of myokine FSTL3 at baseline and their changes at 3 and 12 months with treatment |
| activin-B | 0,3,12 months | circulating levels of activin-B at baseline and their changes at 3 and 12 months with treatment |
| irisin | 0,3,12 months | circulating levels of myokine irisin at baseline and their changes at 3 and 12 months with treatment |
Countries
Greece
Outcome results
None listed