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Young People Get Osteoporosis Too 

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 Osteoporosis Agents to Look for in the future:

PREOS (parathyroid hormone [rDNA origin] for injection)
 
The importance of calcium for healthy bones is well known. Less widely appreciated is the critical role parathyroid hormone (PTH) plays in the regulation of calcium physiology and bone replacement processes. It has now been well established that the normal daily rise and fall of PTH levels in the blood have a profound effect on bone, and that injections of PTH can stimulate the growth of structurally normal new bone in cases where bone has been lost to osteoporosis. In a Phase 2 clinical trial with over 200 postmenopausal women, daily injections of PREOS® (parathyroid hormone [rDNA origin] for injection) produced a clinically and statistically significant average increase in bone mineral density of 7.8% compared to the baseline over a one-year period.

TOP Study
The pivotal Phase 3 clinical trial with PREOS® (the Treatment of Osteoporosis with PTH or TOP Study) was a double-blind, placebo-controlled, multi-national trial. The primary endpoint for this study was vertebral fracture reduction. Secondary endpoints included measuring increases in bone mineral density (BMD) at several skeletal sites. The TOP Study concluded dosing in September 2003.

Women participating in the study received daily, subcutaneous injections of PREOS® or placebo for 18 months. Over an 18 month period, the incidence of new vertebral fracture in the placebo group was 3.37%. The incidence of fracture in the PREOS® treated group was 1.32%. This resulted in a 61% decrease in vertebral fracture incidents when compared to placebo. In general, the percentage of subjects who reported at least one adverse event were similar in the placebo and PREOS® groups.

PREOS® (parathyroid hormone [rDNA origin] for injection) was submitted to the FDA for regulatory review in the U.S. May 2005. Preotact™ (parathyroid hormone [rDNA origin] for injection) was submitted to the EMEA for regulatory review in Europe in March 2005. In May 2006 the European Commission issued marketing authorization for Preotact.

 

calcilytics

In partnership with GlaxoSmithKline, NPS is developing calcilytics, which are orally active, small molecules targeted at bone and mineral disorders, such as osteoporosis. Calcilytics antagonize calcium receptors on parathyroid glands resulting in a transient release of the body’s own stores of parathyroid hormone (PTH). In this way, calcilytics may have the potential to produce the same therapeutic effect as PREOS® (parathyroid hormone [rDNA origin] for injection), but through oral administration rather than through injection. They thus represent an attractive potential follow-on product to PREOS®.

Preclinical studies showed that the increased levels of PTH achieved by calcilytics were equivalent to those achieved by PTH injection and therefore may also have the ability to cause bone growth. GlaxoSmithKline has successfully completed a Phase 1 trial with the lead compound developed from this collaboration. The purpose of this trial was to establish the safety of calcilytics in humans. This trial also illustrated proof-of-concept as surrogate efficacy biomarkers, including PTH levels and bone turnover markers which may indicate new bone formation, were met. NPS has retained co-promotion rights with GlaxoSmithKline in North America for marketing any drugs that result from this collaboration. GlaxoSmithKline plans to initiate a later stage trial later this year.

 

Protelos or Strontium Ranelate
 
 This drug opens a new direction in Osteoporosis medication because it not only slows the work of the osteoclasts but it stimulates osteoblasts to create new bone. This is the first drug that does both.

Protelos (stronium ranelate) has been shown to be highly effective in reducing fractures.

Servier published clinical tests results showing that in a five year study of 5,091post menopausal women with osteoporosis showed:

  • 16% risk reduction in non vertebral fracture (p=0.04)
  • 19% risk reduction in major fragility fractures (hip, wrist, pelvis & sacrum, ribs & sternum, clavicle and humerus)(p=0.031)
  • 36% risk reduction in hip fracture in a high risk elderly population (age > / = 74 years and T score
  • 8.2% increase in bone mineral density at the femoral neck (p<0.001)
  • Protelos was also shown to reduce vertebral fracture by 39% (p<0.001).

Protelos or strontium ranelate, has been approved for use as an Osteoporosis medication in 27 European Countries. An announcement by Servier, the French manufacturer of this drug can be found on their new release page of Servier's web site.

If you wish to review some of the major research studies about Protelos, go to
 Osteoporosis medication: Strontium Ranelate, Protelos

 

Reclast / Aclasta

 

Reclast, which is marketed as Aclasta in other countries, is the first approved treatment for Paget's disease patients to be given as a single-dose infusion compared to current oral therapies that must to be taken daily for up to six months. This medicine was first launched in Germany in May 2005 for Paget's disease and is now approved in more than 50 countries.

Aclasta/Reclast is administered as a single 5 mg, 15-minute intravenous infusion by a healthcare professional.

"We believe Aclasta/Reclast provides a critical new treatment option for people who suffer from Paget's disease," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Furthermore, we are exploring the full clinical potential of this agent in treating other metabolic bone diseases, including postmenopausal osteoporosis."

The approval by the US Food and Drug Administration (FDA) for Paget's disease was based on efficacy and safety data comparing a single dose of Aclasta/Reclast with Actonel (30 mg risedronate) taken daily for 60 days in two identically designed six month trials. Results combined from both trials showed 96 percent of patients taking Aclasta/Reclast responded to treatment compared to 74 percent of patients taking Actonel at six months. Results of these head-to-head studies were published in the September 1, 2005 issue of the New England Journal of Medicine[6].

These studies also demonstrated that Aclasta/Reclast starts working faster, showing a significant difference as early as two months. Patients who took Aclasta/Reclast responded to treatment after an average of 64 days versus 89 days for those taking Actonel. Overall, the number of patients with adverse events was similar in the Aclasta/Reclast and Actonel groups.


About Aclasta/Reclast

HORIZON, the ongoing clinical program of Aclasta/Reclast, is one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases. Approximately 13,000 patients worldwide have participated in the program in more than 400 centers. It is the first program to study a once-yearly dosing regimen for the prevention and treatment of postmenopausal osteoporosis. Other studies involved in the program include prevention of fractures following a hip fracture in men and women, and treatment of corticosteroid-induced osteoporosis and male osteoporosis.

The European Medicines Agency (EMEA) and FDA are currently reviewing submissions for the approval of Aclasta/Reclast as a once-yearly treatment for postmenopausal osteoporosis. Zoledronic acid, the active ingredient of Aclasta/Reclast, is also available under the brand name Zometa for use in other indications.

 

 

Bazedoxifene

 

Bazedoxifene is a second-generation selective estrogen receptor modulator, or SERM. Unlike its older cousin Evista (raloxifene), bazedoxifene doesn't appear to trigger hot flashes in post-menopausal women. Bazedoxifene is currently under FDA review for the prevention of postmenopausal osteoporosis. If approved, bazedoxifene would expand the options currently available to physicians for the prevention of osteoporosis.

 

Oporia (lasofoxifene)

 

Lasofoxifene (Oporia) is a selective estrogen receptor modulator (SERM) under development for the prevention and treatment of osteoporosis and for the treatment of vaginal atrophy.  

Clinical trials point to potent effects of oporia (Lasofoxifene) on bone density

Preclinical studies show Oporia (lasofoxifene) binds to estrogen receptors with an affinity comparable to that of 17beta-estradiol and, in bone, duplicates many of the effects obtained following administration of estrogen. These properties suggest efficacy in osteoporosis and this is indeed confirmed in phase II trials. Compared with raloxifene, the current leading SERM, Oporia (lasofoxifene) appeared more effective in improving spinal bone density in post-menopausal women. Long-term phase II data show that the improvements in bone density are sustained after two years of dosing. Compared with raloxifene, long-term administration of Oporia (lasofoxifene) significantly improved bone parameters, such as bone resorption and lumbar-spine bone mineral density. Reductions in LDL-C were also more pronounced in the Oporia (lasofoxifene) treatment arm compared with raloxifene.

Some 10,500 women have been enrolled in clinical trials in which the effect of Oporia (lasofoxifene) on bone loss prevention and fractures is being assessed. Outcome data from these large-scale trials is awaited with interest.

 

 

 
Nelson, Miriam E. and Wernick, Sarah (2006).  " Strong Women, Strong Bones: everything you need to know to prevent, treat and beat osteoporosis" pp 240-241

 

 

Young People Get Osteoporosis Too Organization
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Revised: 07/19/07.