Official Title: “Potassium Citrate to Prevent Age Related Bone Loss: Pilot Study”

Osteoporosis, a disease in which the bones become weak and are more likely to break, is a major health problem in the United States. Too much acid in the body appears to be linked to loss of calcium via urine, bone loss, and muscle breakdown. The purpose of this study is to determine the effect of various doses of potassium citrate, a supplement that can neutralize acid, on bone density and muscle mass in older, healthy adults.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Over 10 million adults in the United States have osteoporosis, and another 18 million have low bone mass, a risk factor for developing this disease. Each year, approximately 1.5 million fractures are associated with osteoporosis. Adequate intake of calcium and vitamin D is the current nutritional approach to preventing age-related bone loss. However, even with sufficient levels of these nutrients, bone loss can still occur. Too much acid in the body, caused by diet, aging, and protein metabolism, appears to be linked to loss of calcium via urine, bone loss, and muscle breakdown. Potassium citrate can neutralize acids. The purpose of this study is to determine the effect of various doses of potassium citrate on bone density and muscle mass in older, healthy adults.

This study will last 53 weeks. Baseline measurements will take place from Weeks 1 through 4.

During this time, participants will first receive a placebo over a 2-week period.

Participants will then undergo a calcium balance study, involving consumption of certain study foods for 12 days and an overnight stay at the research unit for a calcium absorption test. The calcium balance study will be followed by blood collection and a bone density test.

At Week 5, participants will be randomly assigned to receive either potassium citrate or placebo daily through Week 52. For the first 9 weeks of treatment, there will be weekly blood collection and periodic urine collection for all participants. At Month 6, blood and urine will again be collected, and participants will complete questionnaires on diet and physical activity. From Weeks 50 to 52, participants will be evaluated again with a second calcium balance study, blood collection, questionnaires, and a second bone density test. Final follow-up blood collection will occur at Week 53.

Intervention(s) in this Clinical Trial

• Drug: Potassium citrate
  • kcitrate

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants will receive 90 meq of potassium citrate.
• Experimental: 2
  • Participants will receive 60 meq of potassium citrate.
• Placebo Comparator: 3
  • Participants will receive placebo.

Primary Measures

• Calcium balance, defined as difference between calcium eaten and calcium excreted
  • Time Frame: Measured at Week 53
    Safety Issue?: No

Inclusion Criteria:

• Good general health

Exclusion Criteria:

• Abnormal kidney, liver, or bone function
• Currently taking medications that might affect potassium or bone

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Overall Clinical Trial Officials and Contacts

Deborah Sellmeyer, MD Principal Investigator Univeristy of California, San Francisco  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00282126

Study ID Number: N01 AR052275

ClinicalTrials.gov Identifier: NCT00282126

Health Authority: United States: Federal Government