Circulating Myokine Levels and Bone Metabolism

Study Overview
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Brief Summary
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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
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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

Official Title
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The Role of Myokines in Postmenopausal Osteoporosis

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Drug: Teriparatide
* Drug: Denosumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| premenopausal normal<br>premenopausal women with normal BMD who will be subjected to a single morning, fasting blood drainage | |
| postmenopausal normal<br>postmenopausal women with normal BMD who will be subjected to a single morning, fasting blood drainage | |
| postmenopausal osteopenia<br>postmenopausal women with osteopenia who will be subjected to a single morning, fasting blood drainage | |
| postmenopausal osteoporosis<br>postmenopausal women with osteoporosis who will be subjected to a single morning, fasting blood drainage | |
| hip fracture<br>postmenopausal women at the moment of hip fracture who will be subjected to a single, fasting blood drainage right before osteosynthesis | |
| controls (knee osteoarthitis)<br>postmenopausal women with knee osteoarthritis who will be subjected to a single, fasting blood drainage right before arthroplasty and serve as controls | |
| teriparatide group<br>postmenopausal women with osteoporosis who will be treated with teriparatide (Forsteo) 1 injection of 20mcg subcutaneously daily for 12 months | Drug: Teriparatide<br>* 1 subcutaneous injection daily for 12 months<br>* Other names: rhPTH 1-34;|
| denosumab group<br>postmenopausal women with osteoporosis who will be treated with denosumab (Prolia) 1 injection of 60mg subcutaneously every 6 months for 12 months | Drug: Denosumab<br>* 1 subcutaneous injection every 6 months for 12 months<br>* Other names: RANKL inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follistatin | circulating levels of myokine follistatin at baseline and their changes at 3 and 12 months with treatment | 0,3,12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| activin-A | circulating levels of myokine activin-A at baseline and their changes at 3 and 12 months with treatment | 0,3,12 months | 
| FSTL3 | circulating levels of myokine FSTL3 at baseline and their changes at 3 and 12 months with treatment | 0,3,12 months | 
| activin-B | circulating levels of activin-B at baseline and their changes at 3 and 12 months with treatment | 0,3,12 months | 
| irisin | circulating levels of myokine irisin at baseline and their changes at 3 and 12 months with treatment | 0,3,12 months |