The Effects of Potassium Citrate on Bone Metabolism

NCT00357331 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 0604008486
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Skeletal buffering of chronic acid loads may contribute to a significant amount of bone loss over time. Evidence from a few small short-term studies suggests that basic compounds, namely potassium citrate and potassium bicarbonate may reduce bone loss and improve bone density. The purpose of this study is to evaluate the effects of potassium citrate on bone metabolism. We hypothesize that administration of potassium citrate to postmenopausal women with osteopenia will reduce bone resorption and improve bone mineral density. Postmenopausal women with osteopenia (T score between -1.0 and -2.5) and no history of fracture will be randomized to either daily potassium citrate or placebo for one year. Primary outcomes will be markers of bone turnover, which will be measured over 12 months. Secondary outcomes will be bone mineral density, compliance, and adverse events.

Conditions

Bone Diseases, Metabolic; Osteoporosis, Postmenopausal

Keywords

postmenopausal osteopenia; treatment; bone loss

Outcome Measures

Primary Outcomes (2)

• Urinary-N-telopeptide

  One measure of bone turnover was urinary-NTX as a second void morning urine.

  Baseline,1,3,6,12 months

• P1NP (Amino-terminal Propeptide of Type I Procollagen)

  One measure of bone turnover was P1NP as a morning lab draw.

  Baseline,1,3,6,12 months

Secondary Outcomes (1)

• Number of Participants With Stable Bone Mineral Density (BMD) Over 12 Months at All Sites.

  1 year

Study Arms (2)

Potassium Citrate

EXPERIMENTAL

Potassium Citrate 20 meq twice daily

Drug: potassium citrate

Placebo

PLACEBO COMPARATOR

Placebo

Drug: potassium citrate

Interventions

potassium citrate DRUG

20 meq by mouth in capsule form twice daily

Also known as: uro cit

Placebo; Potassium Citrate

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women, more than 2 years post menopause
• Osteopenia, defined as a T score at the lumbar spine or total hip between -1.0 and -2.5
• No history of prior fragility fracture

You may not qualify if:

• Renal insufficiency
• Use of potassium sparing diuretics
• Use of potassium supplements
• Hyperkalemia
• Secondary causes of osteoporosis or metabolic bone disease
• Delayed gastric emptying
• esophageal compression, intestinal obstruction or stricture
• use of anticholinergic medication
• active urinary tract infection.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Related Publications (1)

• Gregory NS, Kumar R, Stein EM, Alexander E, Christos P, Bockman RS, Rodman JS. POTASSIUM CITRATE DECREASES BONE RESORPTION IN POSTMENOPAUSAL WOMEN WITH OSTEOPENIA: A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL. Endocr Pract. 2015 Dec;21(12):1380-6. doi: 10.4158/EP15738.OR. Epub 2015 Sep 24.

  PMID: 26401577 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis, Postmenopausal

Interventions

Potassium Citrate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Osteoporosis

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

Possible dual effect of calcium citrate, which mitigated the net effect of the alkalinizing treatment. The dose of K-citrate may not be sufficient to produce a change in BMD. Duration of treatment may have been too short to see changes in BMD.

Results Point of Contact

• Title: Assistant Professor of Medicine
• Organization: Weill Medical College

sinhana@med.cornell.edu

212-746-1670

Study Officials

• Naina Sinha Gregory, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double Blind Placebo Controlled Trial

Study Record Dates

• First Submitted: July 25, 2006
• First Posted: July 27, 2006
• Study Start: August 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 12, 2017
• Results First Posted: June 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)