Research on a novel molecule, Strontium Ranelate at Indus Hospital

Karachi: Indus Hospital, a tertiary care multidisciplinary hospital , with its own research center & already working in collaboration with international universities partnered with  a leading pharmaceutical national  company,  for conducting research on a novel molecule, Strontium Ranelate for fracture healing  in Pakistan. Fracture healing is an important topic in orthopedic research. It is estimated that with approximately 70 million trauma cases of which 35% are lower limb fractures occur annually. Tibial diaphyseal fracture is one of the commonest fractures observed in humans, with a high incidence of delayed union, non-union, mal-union and infection.

The study was conducted at The Indus Hospital Karachi from 3rd November 2012 till 03rd August 2013. Patients with closed diaphyseal tibial fracture volunteered as study subjects.

Groups were allocated on the basis of a draw method as Group A and group B.   The groups were blinded and neither the surgical/medical team nor the patients knew about the groups that contained the strontium renalate or the placebo. Randomized double blind control was done among two groups.

The results of the study concluded that Strontium Ranelate is an effective therapy that showed significant improvement in Tibial fractures on all three parameters i.e. X-rays, physical examination & P1NP, The study shows new dimension of bone healing on post fracture cases as Strontium Ranelate mimics the physiological bone remodeling process.

Seventy six patients were enrolled during the study period (between 03rd November 2012 and 03rd August 2013) but out of 76 patients, 63 (82.9%) completed the study, 7 (9.2%) and 6 (7.9%) were dropouts and did not show up for follow-up respectively. Analysis was done per-protocol, i.e. only on the 63 patients who completed 90 days in the study.

Statistically significant improved in fracture healings observed with Strontium ranelate as compared to placebo. Overall the efficacy of Strontium ranelate group was 62.5% v/s 29% of placebo group (p=0.011). Hence data supports the fact that Strontium ranelate promotes fracture healing.

“Indus hospital is making every effort to be on the forefront for providing not only the first class service to patients, “said Dr. Abdul Bari, CEO Indus Hospital, “but also keeping a sharp focus on research & development. Dr.Bari also thanked PharmEvo for its continued valuable support.

PharmEvo (Pvt) Limited COO Syed Jamshed Ahmed who was also present on the occasion highlighted the seriousness of PharmEvo regarding research in Pakistan.  He also mentioned the HRAB (Health Research Advisory board) initiative from PharmEvo, a think tank of senior clinicians, researchers & academicians to develop & promote research ecosystem of Pakistan.

Research can help uplifting image of Pakistan at global medical platform, Dr. Amin Chinoy (Head of Department Orthopaedics) presented the study at EFFORT London shared his experience. He mentioned that there were many Q/A on this study due to exclusivity of subject related to bone healing.

Dr. Mansoor Ali Khan (Prof. of Orthopaedics) presented details of study and scientific evidences, he mentioned that the trail is registered at WHO and bears International Trial number as well, further Fracture healing is the indication which need to studied more and more data is yet to come from International sources. Previously it has been treated with Teriparatide which was quite expansive and beyond the reach of a common man and certainly only anabolic activity may create problem in the long term but Strontium Ranelate has physiological mode of action, works on catabolic activity as well.

In the end Q/A session was conducted where exclusion and inclusion criteria, major outcomes and few other parameters related to study design were discussed.