Status:
COMPLETED
The Effect of Protein Supplementation on Bone Health in Healthy Older Men and Women
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Dietary Supplements (ODS)
Conditions:
Bone Resorption
Osteoporosis
Eligibility:
All Genders
60-85 years
Phase:
PHASE1
PHASE2
Brief Summary
Women and men consuming a low protein diet may be at risk for bone loss. The purpose of this study is to determine whether a daily protein supplement will improve bone health among healthy older adult...
Detailed Description
Dietary protein plays an important role in maintaining balanced calcium levels in the body. Protein's impact on skeletal health remains unclear. It is well accepted that increasing dietary protein res...
Eligibility Criteria
Inclusion
- Willing to travel to one of the study sites
- Women age 60 years or greater, men age 70 years or greater
- Dietary protein intake level between 0.6 g/kg and 1.0 g/kg at baseline
Exclusion
- Active Paget's disease
- Primary hyperparathyroidism or unexplained hypercalcemia
- Untreated hyperthyroidism or hyperthyroidism that has resulted from medical treatment
- Diabetes mellitus type 1
- Cancer diagnosis for solid malignancies (e.g., cancer of the colon, breast,prostate, lungs, lymphocytes) within the 18 months prior to study entry
- Long-term use of chemotherapeutic drugs, aromatase inhibitors, or tamoxifen
- Active treatment for leukemia or multiple myeloma
- Active inflammatory bowel disease
- Life expectancy of less than 2 years
- Current and ongoing use of methotrexate, phenytoin, phenobarbital, or inhaled corticosteroids at a dose of greater than 800 mcg/day
- Use of raloxifene, estrogen, androgen, progesterone, soy isoflavones, oral glucocorticoids, or herbal supplements with estrogenic activity OR a change in dosage of thyroid medications within the 1 year prior to study entry if unwilling to avoid such agents during the duration of the study
- Current use of antiresorptive agents (e.g., calcitonin or bisphosphonates). More information about this criterion can be found in the protocol.
- serum creatinine greater than 1.2 mg/dl
- History of chronic liver disease or evidence of liver disease at screening
- Bilateral hip replacement
- women who have a bone mineral density T-score \< -2.5 at either the hip or spine unless they have decided to decline treatment with conventional anti-osteoporotic medications
- Body mass index (BMI) greater than 32 or less than 19
- Use of proton-pump inhibitors taken twice daily
- Fasting glucose level greater than 110 mg/dl
- Serum albumin level less than 3.0 mg/dl
- Kidney stones or history of kidney stones within the 3 years prior to study entry
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00421408
Start Date
February 1 2007
End Date
September 1 2012
Last Update
April 9 2020
Active Locations (2)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
2
Yale University
New Haven, Connecticut, United States, 06520