Women who discontinue use of Hormone Replacement Therapy may experience rapid bone loss
Study Shows FOSAMAXÒ (alendronate, MSD), the Leading Osteoporosis Treatment, Prevents Bone Loss and Builds Bone Mass for Postmenopausal Women
The recent news that the United States National Institute of Health have ended early one arm of the Women’s Health Initiative has an additional health implication for patients currently on hormone replacement therapy. Results released indicated that long-term use of combined estrogen and progestin (Hormone Replacement Therapy) significantly increased the women’s risk of breast cancer, heart attacks and stroke. Despite the negative risks discovered with HRT use, the study did find that HRT reduced hip fracture risk.
As a result of these findings, many women may discontinue use of HRT and experience a period of rapid bone loss, similar to that seen after menopause. These patients will need to seek medical advice on alternative osteoporosis treatment immediately following discontinuation of HRT to prevent bone loss and the onset of osteoporosis.
“Women who discontinue HRT will lose the bone-health benefits of the drug as soon as they stop taking it,” said Lorraine A.Fitzpatrick, MD, and Professor of Medicine at The Mayo Clinic, USA. “Loss of bone mass can lead to osteoporosis and result in debilitating fractures of the hip and spine. Women who want to protect the strength of their bones should talk to their doctor about the effective alternatives that are available.”
New Zealand bone health experts are concerned about the implications for patients who suddenly come off their HRT medication, particularly if their doctor has recommended long term HRT treatment for bone health as well as menopause.
Dr John Elliot, Physician at the Christchurch Bone Clinic says, “Patients who are taking HRT longterm to protect themselves against osteoporosis may quite reasonably wish to consider stopping it. If they do, then they need to be aware that the protection against osteoporosis will also stop. I would advise them to discuss the situation with their doctor. There is very restricted access to alendronate in New Zealand and no funded access to raloxifene which are both available in Australia, are of proven effectiveness, and are the preferred options to HRT for most women.”
Ian Reid, Professor of Medicine at University of Auckland, says, “In women who have been receiving HRT to treat osteoporosis it is most important that they consult with their doctor for an appropriate strategy for managing their osteoporosis if they decide to discontinue their HRT”.
FOSAMAX protected bones from rapid bone loss
In a study of postmenopausal women who recently had discontinued HRT, FOSAMAX® (alendronate), a non-hormonal therapy for osteoporosis, prevented bone loss and significantly (p<0.001) increased bone density of the spine and hip. This multicenter, international, double-blind 12-month study, presented at the European Symposium on Calcified Tissues, evaluated the efficacy and safety profile of FOSAMAX as compared to placebo in postmenopausal women with low bone mass who had discontinued HRT within three months prior to randomization. A total of 144 women were randomly assigned to either placebo (n=49) or FOSAMAX 10mg daily (n=95) for 12 months. Both groups received a calcium supplement daily, which is recommended practice in osteoporosis management. Study endpoints included bone mineral density (BMD) of the spine, hip and total body, biochemical markers of bone turnover, and tolerability. Results showed that women on placebo experienced rapid bone loss at the spine (p< 0.001) while women treated with FOSAMAX had significant (p<0.001) increases in bone mass at the spine, hip and total body, as measured by BMD. FOSAMAX was well tolerated with no increase in adverse events compared to placebo.
FOSAMAX has been available in New Zealandas a once-daily tablet since 1995. Since February 2000, the Government's drug funding agency PHARMAC has fully funded a more convenient once-weekly dose of the medicine under these criteria: patients who have had one fracture as a result of osteoporosis, and who have a low bone mineral density (-3 standard deviations below a normal value in young adults). It is estimated that over 4,000 New Zealanders currently receive FOSAMAX fully subsidised. Patients at a high risk of osteoporosis and are discontinuing use of HRT may qualify for a FOSAMAX subsidy. If patients fall outside this criteria but are still considered at-risk, their doctor can prescribe the medication with the patient meeting the cost themselves (around $90 per month). FOSAMAX is generally well tolerated, supported by clinical studies that show a low incidence of adverse events.(2)
About osteoporosis
Menopause is a key factor contributing to the development of osteoporosis, which is caused when there is an imbalance in bone-building cycles and more bone is broken down than is replaced. Bone loss can lead to osteoporosis, a disease that causes bones to become more porous, gradually making them weaker, more brittle and prone to fracture.
Approximately 200 million women worldwide suffer from osteoporosis, which afflicts an estimated one-third of women aged 60 to 70. The effect on quality of life for those who suffer osteoporotic fractures can be catastrophic. Fractures of the hip almost always require hospitalization and often results in a loss of mobility and independence. Half of those who suffer hip fractures lose the ability to walk independently, and up to one-third become completely dependent. Hip fractures also are associated with increased mortality.
“This is an important issue for women who are discontinuing HRT,” said Dr. Fitzpatrick. “If a woman wants to prevent or treat thinning bones, she should use a drug designed specifically for osteoporosis. Before stopping HRT, women should talk to their doctor about medications that will prevent future fractures.”
FOSAMAX is a prescription medicine from Merck
Introduced in 1995 for the treatment of postmenopausal osteoporosis, FOSAMAX is the number one prescribed bisphosphonate treatment for osteoporosis worldwide (1). The first oral medication available in a once-weekly dosing regimen for the treatment of osteoporosis, FOSAMAX is the only therapy shown to consistently reduce the risk of fractures at the hip and spine. More than 10 years of clinical studies have shown that FOSAMAX is effective and well-tolerated.
Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme, is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures.
FOSAMAX (alendronate, MSD), was launched in New Zealand in 1995 by Auckland based Merck Sharp & Dohme (NZ) Ltd. Fosamax, 10mg once daily and 70mg once weekly is indicated for the treatment of Post-Menopausal Osteoporosis and Osteoporosis in men and steroid induced Osteoporosis. The company's parent company is Merck & Co., a USpharmaceutical company which over the past 50 years, has discovered and developed more break-through medicines than any other research institution - public or private - in the world.
For more information about FOSAMAX call Merck Sharp & Dohme on 0800 500 673.
1. IMS HEALTH, National Prescription Auditä and the National Disease and Therapeutic Index. Data are for FOSAMAX Once Weekly and FOSAMAX Once Daily for treatment of osteoporosis. Data are as of June 2001 (Moving Annual Total July 2000 through June 2001).
2. Tonino (2000) demonstrates that long-term alendronate treatment is well tolerated and effective. Tonino, RP. Meunier, PJ. Emkey, R et al. Skeletal Benefits of Alendronate: 7-Year Treatment of Postmenopausal Osteoporotic Women. Journal of Clinical Endocrinology and Metabolism. 2000; 85(9): 3109-3115.
THINGS TO KNOW BEFORE USING FOSAMAX (alendronate) 10 & 70 mg tablets:
FOSAMAX is indicated for the treatment of osteoporosis to prevent fractures, including those of the hip and spine (vertebral compression fractures). FOSAMAX should not be taken by patients who have a hypersensitivity reaction, food pipe (oesophageal) abnormalities, low calcium (hypocalcaemia) and have an inability to stand/sit upright for 30mins. Precaution should be taken when administering FOSAMAX to patients with active upper gastrointestinal problems, impaired renal function and calcium or vitamin D deficiency. Common side effects are: abdominal pain, dyspepsia, food pipe (oesophageal) ulcer, difficulty swallowing (dysphagia), abdominal distension, musculoskeletal pain, constipation, diarrhoea, flatulence and headache. FOSAMAX is a prescription only medicine, fully subsidised under special authority for those who meet specified criteria. A prescription charge will apply. Consult your doctor to see if FOSAMAX is right for you, a normal doctors visit fee will usually apply. Use only as directed and if symptoms continue or you have side effects, see your doctor, pharmacist or health professional. Marketed by: Merck Sharp & Dohme (NZ) Limited, Newmarket, Auckland. For detailed prescribing information, consult the data sheet or consumer medicine information (found by clicking on the links below or phoning 0800 500 673) or refer to the Medsafe website www.medsafe.govt.nz . [MPI-FSM-2]
ÒRegistered Trademark. Merck & Co Whitehouse Station, NJ, USA.PRESCRIPTION MEDICINE
Click here for Prescribing Information.
Click here for Consumer Medical Information.
For more information contact:
Angela Hayes, Merck Sharp & Dohme NZ
Ph 09 523 6125
Mobile 021 621 211
Email angela_hayesnz@merck.com
Dr John Elliot
Christchurch Bone Clinic
Mobile 0274 394 076
Email john.elliot@cdhb.govt.nz
Prof Ian Reid
School of Medicine, University of Auckland
Ph 09 373 7599 x 86259
Email i.reid@auckland.ac.nz
12-04-GEN-03-NZ-4252-O
TAPS NA8611
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