Osteoporosis: A Pharmacotherapy Update

Hormone replacement therapy (HRT) was the gold standard in prevention and treatment of osteoporosis. However, with new data that demonstrate an increased risk of cardiovascular disease, breast cancer, venous thromboembolic disease, and stroke, HRT is no longer first-line therapy for most postmenopausal women. The bisphosphonates and raloxifene are antiresorptive agents that have been proven to increase bone mineral density and decrease fractures. These agents are considered to be the therapy of choice in prevention and treatment of postmenopausal osteoporosis. New dosing regimens for the bisphosphonates may improve adherence. The other dramatic change to the pharmacotherapy of osteoporosis is the approval of an agent that stimulates bone formation. Parathyroid hormone has the potential to significantly alter the current treatment approach. In addition, this article reviews the role of calcitonin and ipriflavone combination therapy and discusses data on investigational agents including ibandronate, zoledronic acid, vitamin K, and strontium ranelate.

by : Thomas E. R. Brown, PharmD

Novartis osteoporosis drug approved in EU

Friday, October 05, 2007 10:00:00 AM ET

LONDON, October 5. Swiss pharmaceutical giant Novartis AG (NOT.FSE) Friday announced that the European regulatory authorities had approved the company’s osteoporosis drug, Aclasta.

Novartis mentioned that the once-a-year drug has been approved for the treatment of women with postmenopausal osteoporosis. The drug has recently been approved in the US and is sold under the brand name Reclast. The drug reduces the risk of fractures in areas of the body typically affected by osteoporosis, including the hip, spine, wrists and hips. Meanwhile, the Canadian health regulators announced that they were pulling out Novartis' painkiller, Prexige, from the market due to safety concerns. The drug was recently denied marketing approval in the US.

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New Proof of Genistein’s Efficacy and Safety for Osteopenia and Osteoporosis Published in Annals of Internal Medicine

SCOTTSDALE, Ariz.--(BUSINESS WIRE)--Annals of Internal Medicine has published the results of a two-year clinical study on the impact of genistein on bone loss. The paper, “Effects of the Phytoestrogen Genistein on Bone Metabolism in Osteopenic Postmenopausal Women-A Randomized Trial,” appears in the current issue (June 19, 2007) and details the safety and efficacy of genistein for the dietary management of osteopenia and osteoporosis. The paper reports a significant gain in bone density among patients taking genistein at both 12 and 24 months over both baseline and placebo.

Key study findings include:

* Over 85 percent of the women in the study taking genistein showed a gain in bone density.
* Patients taking genistein in addition to calcium and vitamin D showed a gain in bone density of approximately 3 percent per year over baseline and 6 percent per year over those taking the placebo.
* No adverse events were reported in the study. All participants were monitored for vasomotor symptoms, vaginal bleeding, breast tenderness, endometrial thickness, depression, irritability, insomnia, and gastrointestinal (GI) symptoms, as well as for changes in hematologic, renal and liver function tests. No changes were noted in any of these parameters except for mild GI symptoms.

Patients in the test group of the study used 54 mg/day of highly purified genistein isolated from soy along with calcium and vitamin D. Principle Investigator for the study, Francesco Squadrito, M.D., Professor of Pharmacology and Head of Clinical Pharmacology, School of Medicine, University of Messina, Italy, explains that there were some interesting aspects to the study: “The placebo in this study was not an inactive pill; instead it was the current standard of care for osteopenia – calcium plus vitamin D. Unlike other research in this area, this study was controlled for soy intake and additional supplement use, either of which may confound the results of a study.”

The National Osteoporosis Foundation reports that osteoporosis currently afflicts more than 10 million Americans, while an additional 34 million have osteopenia. Osteopenia is the required precursor to osteoporosis. The lack of safe, efficient therapy for osteopenia beyond lifestyle changes with calcium and vitamin D leaves many patients and physicians with a lack of options.

Fosteum, the first prescription product developed to safely meet the nutritional requirements of patients with osteopenia and osteoporosis, is being introduced nationally by Primus Pharmaceuticals, Inc. Fosteum’s genistein, which was evaluated in this clinical study, is highly concentrated and cannot be achieved simply through dietary change. According to Dr. Squadrito, “To obtain the amount of genistein found in two capsules of Fosteum, one would have to consume 26 pounds of soybeans or over two gallons of soy milk each day.” Since no other product contains the same genistein as found in Fosteum, Dr. Squadrito urges caution in transferring the information in his paper to supplements purporting to contain genistein: "Supplements contain much lower concentrations of genistein and have other, sometimes unidentified, compounds in addition to genistein.”

Dong Wha and Procter & Gamble Pharmaceuticals Form Alliance for Osteoporosis Treatments

SEOUL, Korea, July 3 /PRNewswire/ -- Dong Wha Pharmaceutical Ind. Co, (Korea Exchange: 000020) and Procter & Gamble Pharmaceuticals, Inc. (P&GP), a subsidiary of The Procter & Gamble Company , today announced a strategic alliance under which P&GP will have rights to develop and commercialize a novel class of molecules for the treatment of osteoporosis. The agreement includes Dong Wha's novel drug DW1350 and a family of back up compounds.

Under the terms of agreement, Dong Wha will retain rights for specific countries in Asia and will grant P&G exclusive rights for the rest of the world. Dong Wha will receive an upfront fee, development and commercial milestone payments, and royalties on product sales. Total payments, excluding royalties, for successful development and commercialization of products, including DW 1350, could reach $511 million. The parties may also negotiate a supply agreement in which Dong Wha would have an opportunity to supply active pharmaceutical ingredient and finished products to P&GP and its affiliates.

"It is a major milestone in our process for becoming a global pharmaceutical company," said Mr. Kil-Joon Yoon, President and CEO of Dong Wha. "P&GP's profound understanding of patient need, together with its proven product development skills in the osteoporosis field, makes them an ideal partner, and we are delighted that P&GP shares our objective of developing new therapeutic agents that improve bone quality."

"Dong Wha's approach to scientific discovery and the potential of this new class of compounds as a novel treatment for osteoporosis is very impressive and a perfect fit as we look to broaden our portfolio in the musculoskeletal therapeutic area," said Tom Finn, President, Global Health Care, The Procter & Gamble Company. "It is our goal to be a leader in the area of bone health by developing a range of therapy options that will bring relief to the many patients suffering from musculoskeletal diseases."

Get Your Three A Day To Help Reduce The Risk Of Osteoporosis

June is National Osteoporosis Month and to help highlight the condition in which bones become weakened and prone to breaking, Cravendale milk is encouraging people to add more calcium to their diets. Around 3 million people in the UK suffer from osteoporosis*, but it’s easier than you think to maintain healthy bones.

A calcium rich diet goes a long way to ensure that bones stay strong throughout our lifetimes. The Dairy Council recommends having three portions of dairy products a day to meet the full daily requirement for calcium and to improve intake of other essential nutrients such as zinc, protein, and vitamin B12. With one portion being equivalent to a 200ml glass of milk*, it’s as simple as adding a glass of pure, filtered milk like Cravendale to your diet.

Carole Barr from The Dairy Council says “By making sure our bodies get the bone-building nutrients they need, right through from childhood to adulthood, the risk of developing osteoporosis can be reduced. Women are most at risk with bone mass disappearing from as young as 35 but as many as one in eight boys and one in four girls aged 11 to 14 years are not getting enough calcium so it’s vital we all build strong bones for the future.”

Cravendale is different to other milk because it’s been filtered to remove more of the bacteria that cause milk to sour, while leaving all the goodness behind. This leaves fresher tasting milk, which still contains all the vitamins and nutrients needed to keep they body healthy, and pave the way to stronger bones in later life.

While calcium is found in a wide range of foods such as green vegetables, nuts and seeds, dairy products are particularly good sources. This is due to the fact that the calcium in dairy foods such as milk, cheese and yoghurt is more easily absorbed and processed by the body than calcium from other foodstuffs.*

So when it comes to maintaining strong bones and actively preventing osteoporosis, keeping a bottle of Cravendale the fridge could do so much more for your body than just taste good!

Cravendale is available in skimmed, semi skimmed and whole varieties from all good shops. Cravendale also comes in handy on the go bottles in semi skimmed, Hint of…Strawberry and Hint of…Vanilla flavours.

To learn more about why filtration makes Cravendale so special, check out Milkmatters.co.uk.

* Source: The Dairy Council

Solis Women’s Health Enters North Carolina Market

AUSTIN, Texas--(BUSINESS WIRE)--Solis Women’s Health announced today that it has acquired Bertrand Breast and Osteoporosis Center of Greensboro, North Carolina. The Bertrand Center, founded by Dr. Margaret Bertrand in 1983, is the oldest independent breast center operating in Greensboro and is an acknowledged leader in breast cancer diagnosis in the Southeastern United States.

Solis CEO Brad Hummel commented, “The acquisition of Bertrand Breast and Osteoporosis Center paves our way into northern North Carolina and the dynamic regions known as the Piedmont Triad and Piedmont Triangle. We are fortunate to be partnering with a physician and professionals as experienced and committed as Dr. Bertrand and her staff. As a breast cancer survivor, Dr. Bertrand brings a unique perspective to patient care. Her experience has reinforced her advocacy of the life-saving value of highly specialized detection and diagnosis in the cancer care continuum.”

Dr. Bertrand commented, “I am delighted to be joining Solis. The Solis model aligns completely with my view that breast care begins with screening mammography interpreted by specialized breast imagers. By managing a patient through comprehensive diagnosis we demonstrably enhance the confidence of both referring physicians and those participating in required therapy.”

Brad Hummel added, “This initial acquisition will serve as an anchor for a broad initiative to expand our delivery system in North Carolina. Through the deployment of community-based screening facilities networked around centers of excellence, we believe we will dramatically improve access and the quality of care for women within the region.”

The Bertrand facility is the only regional diagnostic center to offer breast-specific gamma imaging. This innovative technology, in addition to bone densitometry, ultrasound and stereotactic biopsy, will be complemented by the impending implementation of full-field digital mammography.

New Jersey Women Recognized For Efforts To Reduce Osteoporosis


New Jersey Department Of Health
Osteoporosis

New Jersey Interagency Council on Osteoporosis has presented the 2007 New Jersey Osteoporosis Prevention Awards to three New Jersey residents.

The awards are presented annually to dedicated volunteers and professionals each year in May during Osteoporosis Awareness and Prevention Month.

Marjorie Bissinger of Parsippany was honored with the Professional Award for her outstanding efforts to reduce and prevent osteoporosis-related fractures through exercise, good posture and balance. A physical therapist and the president of Work Fit Consultants, she lends her professional expertise in support of the DHSS Project Healthy Bones program, a peer-led osteoporosis education and exercise program conducted throughout New Jersey.

Elizabeth Hontz of Clinton received the Consumer Award for many years of devoted service as a volunteer leader for Project Healthy Bones. Through her efforts, program participants say they are more health conscious, and have changed their behavior thanks to her sharing of resources and weekly discussions.

Sally Fullman of Murray Hill received the Consumer Award for her proactive approach to osteoporosis issues. Ms. Fullman has personally linked concerned consumers with medical experts to answer questions on critical health information. An active volunteer peer leader for Project Healthy Bones, Ms. Fullman provides special charts and materials to help participants meet their personal goals.

The ICO is dedicated to the development, implementation and evaluation of a comprehensive osteoporosis prevention and education program to benefit New Jersey residents and professionals.

Osteoporosis, known as the Silent Disease, is a serious condition in which bones become thin, brittle and are easily broken. According to the National Osteoporosis Foundation, nearly half of all women and 20 percent of all men can be expected to sustain an osteoporosis-related fracture in their lifetime. Osteoporosis can impair an individual's ability to walk unassisted, and often results in prolonged or permanent disability, institutionalization or death.

Osteoporosis is largely preventable through healthy behaviors, including a balanced diet rich in calcium and vitamin D, weight-bearing exercise, a healthy lifestyle without smoking or excessive alcohol, bone density testing and medications when appropriate.