N/A
N=40
Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia
Osteopenia · Bone Disease, Metabolic
Bottom Line
View on ClinicalTrials.gov: NCT02731820 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Changes in Serum Level of Carboxyterminal Cross-linked Telopeptide of Type I Collagen (CTX); Over Time, i.e. Baseline, 3 Months, 6 Months. — 0.64; 0.64; 0.63; 0.56 µg/L — p=0.172
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Potassium citrate (Dietary_supplement); Placebo (Dietary_supplement); Vitamin D3 (Dietary_supplement); Calcium carbonate (Dietary_supplement)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Istituto Ortopedico Rizzoli
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Serum Level of Carboxyterminal Cross-linked Telopeptide of Type I Collagen (CTX); Over Time, i.e. Baseline, 3 Months, 6 Months. |
0.64; 0.64; 0.63; 0.56; 0.53; 0.54 | 0.172 |
| PRIMARY Changes in Serum Levels of "Tartrate-resistant Acid Phosphatase 5b Isoenzyme" (TRAcP5b) Over Time, i.e. Baseline, 3 Months, 6 Months. |
2.35; 2.64; 2.79; 2.85; 2.69; 2.25 | 0.954 |
| PRIMARY Changes in Serum Levels of "N-terminal Propeptide of Type I Procollagen" (P1NP) Over Time, i.e. Baseline, 3 Months, 6 Months. |
17.45; 18.82; 16.24; 18.39; 14.97; 16.77 | 0.213 |
| PRIMARY Changes in Serum Levels of "Bone-specific Alkaline Phosphatase" (BAP) Over Time, i.e. Baseline, 3 Months, 6 Months. |
21.89; 20.36; 19.81; 18.27; 16.83; 15.79 | 0.094 |
Summary
The purpose of this study is to investigate whether the use of alkali compounds, i.e. potassium citrate (K3C6H5O7, hereinafter KCitr) is effective in preventing the progression of osteopenia.
A randomized clinical trial (RCT, placebo-controlled, double-blind) has been planned to evaluate the effect of the daily administration of KCitr (3 g/die, K 30 mEq).
The efficacy will be evaluated by comparing the circulating levels of bone turnover markers at the baseline and after the treatment (3, 6 months).
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women, more than 5 years post menopause
- Osteopenia (T-score -2.5)
- Low risk of fracture (FRAX: < 20 major osteoporotic; < 3 hip fracture)
Exclusion Criteria
- Hyperkalemia
- Renal insufficiency
- Nephrolithiasis
- Use of potassium sparing diuretics
- Use of potassium supplements
- Use of therapies influencing bone metabolism (e.g. corticosteroids, thiazide diuretics, aromatase inhibitors, estrogens)
- Use of protonic pump inhibitors
- Current or recent use of bisphosphonates (stopped less than three years prior to the start of the study)
- Gastrointestinal disorders that hamper nutrient absorption;
- Mental or psychiatric disorders that preclude the possibility of correctly adhering to the protocol
Data sourced from ClinicalTrials.gov (NCT02731820). 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.