Researchers at Indus Hospital discover a new indication for use of Strontium Ranelate

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Enhanced accelerated fracture healing, bone union

Researchers at Indus Hospital discover a new
indication for use of Strontium Ranelate 

KARACHI: Researchers at multidisciplinary Indus Hospital at Karachi have claimed to have discovered yet another indication for the use of Strontium Ranelate which is available for the last many years and is being already used for the treatment of osteoporosis. It is available in Pakistan with the name of Onita. Speaking at a press conference on August 16th2014, they said that 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 further showed that new dimension of bone healing on post fracture cases as Strontium Ranelate mimics the physiological bone remodeling process.

Dr. Mansoor Ahmad, Dr. Kamran Ahmad and Dr. Amin Chinoy consultant
orthopaedic surgeons at Indus Hospital addressing a press conference
to highlight the new indications for the use of Strontium Ranelate which
accelerates and enhances fracture healing and bone union.
Dr. Abdul Bari Khan Chief of Indus Hospital, Mr. Jamshed Ahmad
COO PharmEvo and Mr. Shakil Ahmed Director Marketing and
Sales PharmEvo are also present on the occasion.

Sharing the results of the study Dr. Mansoor Ahmad, Dr. Kamran Ahmad and Dr. Amin Chinoy the consultant orthopaedic surgeons at the Indus Hospital said that the study was conducted from 3rd November 2012 till 03rd August 2013. Patients with closed diaphysealtibial fracture volunteered as study subjects. It was a double blind clinical trial and the study protocol was approved by the Hospital Ethics Committee and the trial was also registered in Trial Registry. All the participants gave informed consent for the study. 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.
Seventy six patients were enrolled during the study period but only 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 (31 in one group and 32 in the other group) who completed 90 days in the study. Statistically significant improvement in fracture healings was 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.
Replying to a question regarding the inclusion and exclusion criteria, it was stated that the patients between the ages of 18-60 years who were suffering from tibial fracture were included. These were close fractures of less than thirty days. Inclusion criteria also included that they had no prior surgical treatment. Exclusion criteria included patients with liver failure, kidney failure, children and those patients who needed bone grafting. Clinical as well as radiological criteria both were used to assess the efficacy of the drug in fracture healing. The patients had plate fixation and then put on this drug and then they were evaluated after three months. The clinical impression about fracture healing was not significant but on X-ray results showed it much better. On the whole patients had significant improvement in their fracture healing and bone union. Responding to yet another question regarding the side effects or if any patient had to be withdrawn due to adverse events, Dr. Mansoor said the known side effects of this drug are diarrhea and skin rashes but we did not notice any such side effects nor any patients had to be withdrawn from the study due to adverse effects. Prior to this study we had anecdotal evidence regarding its fracture healing properties but no published data was available. Hence we decided to conduct this trial, he added.
Fracture healing, they stated, is an important topic in orthopedics and out of approximately seventy million trauma cases, 35% are lower limb fractures which occur annually. Fracture of tibia is one of the commonest fractures observed in humans with a high incidence of delayed union, non-union, mal-union and infections. Hence if these patients with fractures are put on Strontium Ranelate immediately it will enhance and accelerate their fracture healing as well as bone union. Dr. Amin Chinoy said that the results of this study were presented at EFFORT an important orthopaedic conference in London recently and it aroused lot of interest among the participants. Dr. Mansoor Ahmad said that this fracture healing properties of this drug needs to be studied further and more data may be coming in the days to come from international sources. Previously these fractures were being treated with Teriparatide which was quite expensive and beyond the reach of common man. Yet another advantage with Strontium Ranelate is that it has physiological mode of action and works on catabolic activity as well. Findings of our study, he further stated, will be submitted for publication shortly.
Earlier Dr. Abdul Bari Chief Executive Officer of Indus Hospital in his introductory remarks highlighted the importance of research and said that there is lot of data in Pakistan which is a gold mine but it is not published. Hence, we at Indus Hospital decided to have facilities for research from the very first day. We have collaboration with research organizations and research was one of our core values apart from providing free treatment. Mr. Jamshed Ahmad Chief Operating Officer of PharmEvo which had sponsored this clinical trial in his speech on the occasion said that they were delighted with this new finding. Research is very close to our heart. He disclosed that when PharmEvo launched Simvastatin molecule, Dr. Basit conducted a study at BIDE. When we introduced Clopidogrel, a study was done at NICVD by Prof. Azhar Farooqui which proved that our product had better efficacy profile as compared to the branded drug; the reason being that the branded drug was being brought to Pakistan through illegal means in those days and during transit, it lost some of its efficacy. PharmEvo, he said, had already established Health Research Advisory Board with the prime objective of helping researchers and promoting the research culture in Pakistan.

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