According to new research published online in The Journal of Clinical Endocrinology & Metabolism, treatment with Jungbunzlauer’s Active Pharmaceutical Ingredient Tripotassium Citrate (TPC) leads to significant increases in bone mineral density (BMD) and improvement of bone microarchitecture in healthy elderly people.
The randomised, double-blind, placebo-controlled study (Jehle S, Hulter HN and Krapf R, Effect of Potassium Citrate on Bone Density, Microarchitecture, and Fracture Risk in Healthy Older Adults without Osteoporosis: A Randomized Controlled Trial. Published online before print November 15, was led by Prof. Reto Krapf of the University of Basel. 201 elderly men and women (>65 years old) with normal baseline BMD received either 60mEq/d of alkalizing TPC via UROCIT K tablets (Mission Pharmacal, TX) or placebo over 24 months. Both groups were supplemented with 500mg calcium and 400 IU vitamin D3. The Researchers’ objective was to assess the applicability of TPC and its effect on bones in the context of its ability to neutralise the acid load imposed by our modern western diet.
The results against placebo after 24 months were reported to be as follows:
- Significant increase of lumbar spine (+1.7%) at areal BMD, as measured by dual-energy xray absorptiometry (aBMD via DXA, primary endpoint)
- Significant increases of trabecular densities in both radii and both tibiae as measured by high-resolution peripheral quantitative computed tomography (vBMD via HR-pQCT, secondary endpoint)
- Significant decrease of fracture prediction score as analyzed by WHO’s FRAX tool
The authors conclude that TPC “…administered in a background of vitamin D and calcium supplements is well tolerated and constitutes an inexpensive intervention to increase bone aBMD and trabecular vBMD and to improve bone microarchitecture in healthy elderly people with normal bone mass. A therapeutic, i.e. antifracture, efficacy of the alkali intervention, alone or in combination with existing anti-osteoporosis drugs, is suggested by the decrease in fracture risk by FRAX but will need assessment in appropriately designed, large multicenter trials.”
TPC is produced in Jungbunzlauer’s Ladenburg, Germany plant according to cGMP guidelines. Due to its existing usage as an oral alkalising agent to treat renal acidosis and kidney disease, Jungbunzlauer Ladenburg holds a Drug Master File for TPC (DMF #14847) and has been registered with the US FDA since May 2000 and with German authorities since 2011.
In October 2012, Jungbunzlauer TPC was granted a Certificate of Suitability (CEP) by the competent European Authorities.