A Study of the Effects of Aging on Bone Formation in Men
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-008560
Sponsor Protocol Number: 14-008560
About this study
The purpose of this study is to identify new mechanisms responsible for age related impairment in bone formation by studying specific genes and pathways related to bone formation.
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 men
- Young, aged 25-40 years
- Old, aged 60-80 years
Exclusion Criteria
- Abnormality in any of the screening laboratory studies
- If found to have low body stores of vitamin D (serum 25-hydroxyvitamin D of < 20 ng/ml), subjects will be treated with 1000 IU/day of vitamin D for 8 weeks and then rechecked
- If the level is still < 20 ng/ml, they will receive a second 8 week course of vitamin D
- If, following that, the level is still < 20 ng/ml, they will not continue in the study and will be referred to their primary physician for further evaluation
- Presence of significant liver or renal disease
- Malignancy (including multiple myeloma)
- Malabsorption
- Diabetes
- Hypoparathyroidism
- Hyperparathyroidism
- Acromegaly
- Cushing’s syndrome
- Hypopituitarism
- Severe chronic obstructive pulmonary disease
- Treatment with any of the following drugs
- 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)
- Testosterone therapy
- Teriparatide (within the past year)
- Bisphosphonates within the past 3 years
- A clinical history of osteoporotic fracture (vertebral, hip, or distal forearm)
- To avoid confounding by hypogonadism, particularly in the elderly males, we will obtain free testosterone levels in all subjects and exclude those with levels < 9 ng/dL (the lower limit of normal in our laboratory)
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Sundeep Khosla, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available