The Effect of Protein Supplementation on Bone Health in Healthy Older Men and Women

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Bone Resorption, Osteoporosis

In brief

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 adults.

Key facts

Study ID

NCT00421408

Run by

Yale University

People needed

208

Starts

2007-02-01

Expected to finish

2012-09-01

Last updated by the study team

2020-04-09

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Connecticut Health Center — Farmington, Connecticut, United States
• Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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