December 12/University at Basel -- 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 randomized, double-blind, placebo-controlled study was led by Professor Reto Krapf of the University at Basel. The study involved 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 during a 24-month period. Both groups were supplemented with 500mg calcium and 400 IU vitamin D3. Researcher said their objective was to assess the applicability of TPC and its effect on bones in the context of its ability to neutralize the acid load imposed by modern western diets.

The results against placebo after 24 months were reported as follows:
- Significant increase of lumbar spine (+1.7%) at areal BMD, as measured by dual-energy x-ray 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 (secondary endpoint)

Study authors concluded 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.”

Jungbunzlauer produces TPC at the company’s Ladenburg, Germany, plant according to cGMP guidelines.Due to its existing usage as oral alkalizing agent to treat renal acidosis and kidney disease, Jungbunzlauer Ladenburg GmbH holds a Drug Master File for TPC (DMF #14847) and is 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.

*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, 2012: http://jcem.endojournals.org/content/early/2012/11/14/jc.2012-3099