A Study of How Age Affects Osteoclast Inhibition and Bone Formation

Overview

About this study

This protocol addresses three main questions. How are gene expression changes in bone cells affected by aging? Is aging associated with decreased signaling between bone cells? How does treatment with the osteoporosis medication denosumab affect bone cell signaling?

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Normal premenopausal women aged 25-40 years
Normal postmenopausal women aged 60-80 years
- at least 5 years 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 year)
- 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 years)
- Denosumab
- Estrogen (E) therapy within the past year
- Treatment with a selective E receptor modulator within the past year
- Teriparatide within the past year
- 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Sundeep Khosla, M.D.	Closed for enrollment	Contact information: Louise McCready R.N. (507)284-4329 mccready.louise@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sundeep Khosla, M.D.

Closed for enrollment

Contact information:

Louise McCready R.N.

(507)284-4329

mccready.louise@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials