Effect of Neutralization of Endogenous Acid Production on BMD and Bone Microarchitectural
This study has been completed.
Sponsor:
Kantonsspital Baselland Bruderholz
Information provided by (Responsible Party):
Reto Krapf, Kantonsspital Bruderholz
ClinicalTrials.gov Identifier:
NCT00509405
First received: July 30, 2007
Last updated: April 23, 2012
Last verified: April 2012
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Purpose
Hypothesis: Neutralization of acid production induced by the Western diet with oral administration of potassium citrate increases bone mineral density and bone mass as well as skeletal muscle mass and strength in elderly people (> 65y).
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: potassium citrate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone in Humans |
Resource links provided by NLM:
Drug Information available for:
Potassium bicarbonate
Potassium citrate anhydrous
Sodium citrate
Potassium citrate
Potassium chloride
U.S. FDA Resources
Further study details as provided by Kantonsspital Baselland Bruderholz:
Primary Outcome Measures:
- BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
- effect on skeletal muscle mass and strength [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
- effect on left ventricular muscle mass [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- effect on carotid media-intima thickness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Hypoxia-induced endothelial vasorelaxation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 202 |
| Study Start Date: | July 2007 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Potassium citrate |
Drug: potassium citrate
6 times 10 mEq per day, oral for 24 months
|
Detailed Description:
We will perform a prospective, randomized, placebo-controlled trial evaluating the effect of K citrate on bone mineral density, microarchitectural composition of bone,nutritional parameters, lean body mass, parameters of skeletal muscle mass and strength, 24h and exercise induced blood pressure changes in otherwise healthy, elderly ambulatory subjects of both genders.
Potassium citrate (60 mEq) is supplied as tablets with a wax matrix (10 mEq of citrate per tablet) and ingested in three doses/day. All subjects will receive daily oral 500 mg of calcium and 400 IU of vitamin D to ensure adequate calcium and vitamin D supply.
Eligibility| Ages Eligible for Study: | 65 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Men and women, 65 to 80y, tscores at L2-L4 0 to -2.5
Exclusion Criteria:
- Treated or necessity to treat low BMD (t-score L2 to L4 <-2.5)
- Any major medical illness that would possibly need hospitalization and/or be followed by foreseeable complications within 12 months and/or have a life-expectancy of less than 5 years
- Stable serum creatinine > 150 umol/l and/or known Type IV renal-tubular acidosis (hyperkalemia)
- vegetarians
- concommitant drug prescriptions: systemic and topical glucocorticoids, systemically acting estrogens (topical allowed): both within the last 6 months. antiosteoporosis drugs: bisphosphoponates, fluoride, calcitonin, all within the previous 12 months.
- vitamin D deficiency at screening visit
- technical difficulties to delineate bone area of interest during the screening visit
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509405
Locations
| Switzerland | |
| Department of Medicine, Kantonsspital Bruderholz | |
| Bruderholz/Basel, BL, Switzerland, CH-4101 | |
Sponsors and Collaborators
Kantonsspital Baselland Bruderholz
Investigators
| Principal Investigator: | Reto Krapf, MD | Department of Medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz/Switzerland |
More Information
Additional Information:
No publications provided
| Responsible Party: | Reto Krapf, Professor of Medicine, Kantonsspital Bruderholz |
| ClinicalTrials.gov Identifier: | NCT00509405 History of Changes |
| Other Study ID Numbers: | 316/06, NFP 53: 4053-110259 |
| Study First Received: | July 30, 2007 |
| Last Updated: | April 23, 2012 |
| Health Authority: | Switzerland: "Steering committee of the Swiss National Foundation NFP 53" |
Keywords provided by Kantonsspital Baselland Bruderholz:
|
Endogenous acid production metabolic acidosis potassium citrate osteoporosis |
sarcopenia hypertension Effect of potassium citrate on bone mineral density and bone mass |
Additional relevant MeSH terms:
|
Citric Acid Potassium Citrate Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents |
Molecular Mechanisms of Pharmacological Action Diuretics Natriuretic Agents Physiological Effects of Drugs Expectorants Respiratory System Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013