Osteoclast Inhibition and Bone Formation

• Status: Completed
• Trial end date: 2016-10-25
• Target enrollment: 0
• Participant gender: Female

Summary

This protocol addresses: 1) How gene expression changes in bone cells are affected by aging? 2) Is aging associated with decreased signaling between bone cells? 3) How does treatment with the osteoporosis medication denosumab affect bone cell signaling?

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Denosumab

Criteria

• Inclusion Criteria:

• normal premenopausal women aged 25-40 years

• normal postmenopausal women aged 60-80 years

• at least 5 yrs since their last menses

• follicle stimulating hormone (FSH) > 20 IU/L

• Exclusion Criteria:

• Abnormality in any of the screening laboratory studies

• Presence of significant liver or renal disease

• Malignancy (including myeloma)

• Malabsorption

• Diabetes

• Hypoparathyroidism

• Hyperparathyroidism

• Acromegaly

• Cushing's syndrome

• Hypopituitarism

• Severe chronic obstructive pulmonary disease

• Undergoing treatment with any medications that affect bone turnover, including the following:

• adrenocorticosteroids (> 3 months at any time or > 10 days within the previous yr)

• anticonvulsant therapy (within the previous year)

• pharmacological doses of thyroid hormone (causing decline of thyroid stimulating hormone below normal)

• calcium supplementation of > 1200 mg/d (within the preceding 3 months)

• bisphosphonates (within the past 3 yrs)

• denosumab

• estrogen (E) therapy within the past year

• treatment with a selective E receptor modulator within the past year

• teriparatide within the past yr

• Clinical history of osteoporotic fracture (vertebral, hip, or distal forearm)

• Recent (within the past 6 months) fracture

• Serum 25-hydroxyvitamin D levels of < 20 ng/ml