FDA Safety Announcement About Bisphosphonates

Most readers who visit my blog have either already stopped taking bisphosphonates for osteoporosis or are seriously contemplating doing so and switching to strontium or something else. ABC News has recently reported on femur fractures occurring in some patients following several years on bisphosphonates. In response to those news reports and the outcry from viewers, on 03/10/2010, the FDA issued a Drug Safety Communication on bisphosphonates and femur fractures. Here is part of that announcement:

"Patients and healthcare professionals may have questions about oral bisphosphonate medications and atypical subtrochanteric femur fractures – fractures in the bone just below the hip joint. Oral bisphosphonates are commonly prescribed to prevent or treat osteoporosis in postmenopausal women. Common brand names of medications in this class include Fosamax, Actonel, Boniva, and Reclast."

"Recent news reports have raised the question about whether there is an increased risk of this type of fracture in patients with osteoporosis using these medications. At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue." See the entire FDA announcement at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm

Report any adverse events with the use of oral bisphosphonates to FDA's MedWatch program:

1-800-332-1088
1-800-FDA-0178 Fax
MedWatch Online2
Regular Mail: Use postage-paid FDA Form 35003
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787

Strontium Ranelate Reduces Vertebral Fracture Risk

The primary goal of any osteoporosis treatment is prevention of stress fractures. The following abstract is from one of the most recent studies on strontium ranelate highlighted by the International Osteoporosis Foundation (IOF) at www.iofbonehealth.org/pio/latest-issue/volume-10-issue-4-2009/overview.html:

"Meunier et al report on 1649 osteoporotic women randomized to strontium ranelate (SrR) or placebo for four years followed by a one-year treatment-switch period for half of the patients. Over four years, risk of vertebral fracture was reduced by 33%. Among patients with two or more prevalent vertebral fractures, risk reduction was 36%. Lumbar BMD increased over five years in patients who continued with SrR, and decreased in patients who switched to placebo. Osteoporos Int 2009;20:1663-73"

Strontium Citrate Clinical Trial Still Recruiting

"The researchers are seeking post-menopausal women who are at least one year but less than five years past their last menstrual period. Participation in the study will include a screening visit with blood draw at UC Davis Medical Center, followed by a blood draw and free DEXA scan at the Veterans Administration Northern California Health Care Center."

"Participants will be randomly assigned to one of two groups. One group will take strontium citrate plus calcium and vitamin D for three months, while the other group will take a placebo plus calcium and vitamin D for three months. During the three-month period, participants will visit UC Davis Medical Center three times for short questionnaires and blood draws. DEXA scans and test results can be provided to participants.For more information or to schedule a screening visit, contact Stephanie Burns, study coordinator, at (530) 754-7576 or (916) 734-5562 or scope@phs.ucdavis.edu."

Update On Strontium Citrate Clinical Trial

Here is the latest update on the Strontium Citrate Clinical Trial known as the Scope Study and being conducted at the University of California at Davis (UCD). Per Stephanie Burns, study coordinator, "we are currently half-way through our recruitment period. We should have results in about a year’s time."

Osteologix To Market Strontium Malonate In EU By 2012

On December 09, 2009, Osteologix Inc. (OLGX.OB) announced that it should be prepared to file a marketing application in 2011 in the European Union for its proprietary strontium therapy, NB S101 (strontium malonate). If successful, this will be Osteologix' first marketing approval of NB S101 for the treatment of postmenopausal osteoporosis. Following the successful completion of the company's initial Phase 2 study comparing NB S101 (strontium malonate) to Protelos (strontium ranelate), which is marketed by Les Laboratoires Servier (Servier), Osteologix sought feedback on its development program from various regulatory authorities. Osteologix has determined that the company will be positioned to pursue a European Marketing Application for NB S101 as a treatment for post-menopausal osteoporosis. The company expects that it can complete the additional development work in 2010 and will be prepared to file a marketing application during the first half of 2011. This pathway is in keeping with the Company's overall strategy of developing its once-daily strontium tablet for the osteoporosis market. Osteologix has initiated discussion with potential regional and global partners and believes that the selected partner(s) will be able to begin marketing the product by 2012, providing them with at least 12 years of patent protection in the European Union.

This is an abbreviated version of a press release by Osteologix. See the original at www.osteologix.com.

Strontium Ranelate Reduces Fracture Risk

The TROPOS study of strontium ranelate (Protelos) reached the following conclusions about fracture risk reduction:

The number of patients experiencing a hip fracture was reduced by 36% (P=0.046) over 3 years of treatment in postmenopausal women over 74 years of age.

Protelos also reduced the relative risk of nonvertebral fracture by 16% (P=0.04) over 3 years compared with placebo.

Protelos reduced the risk of major fragility fractures (fracture of the hip, wrist, pelvis and sacrum, ribs and sternum, clavicle, humerus) by 19% (P=0.031) over 3 years compared with placebo.

In patients without prevalent vertebral fracture at baseline, Protelos reduced their risk of experiencing a first fracture by 45% (P<0.001).