Phase 2 N=208 Randomized Double-blind Treatment

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

Bone Resorption · Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT00421408 ↗

Enrolled (actual)

208

Serious AEs

8.6%

Results posted

Aug 2013

Primary outcome: Primary: Change in Anterior-posterior Spine Bone Mass Density Measured by Dual Energy X-ray Absorptiometry (DXA) Compared to Baseline — 0.51; 0.51 percentage change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Whey protein supplement (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Yale University
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Anterior-posterior Spine Bone Mass Density Measured by Dual Energy X-ray Absorptiometry (DXA) Compared to Baseline	0.51; 0.51	—
PRIMARY Change in Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) Compared to Baseline	-0.07; -2.64	—
PRIMARY Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at Baseline	1.10; 1.13	—
PRIMARY Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 9 Months	1.14; 1.12	—
PRIMARY Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 18 Months	1.14; 1.12	—
PRIMARY Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at Baseline	106; 103	—
PRIMARY Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at 18 Months	106; 99.3	—

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 adults.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00421408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.