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Fri 15 Jun, 2007 03:44 am
New preventive therapy for osteoporosis
Jun 1, 2007
By: Judith Asch-Goodkin
Patient Care Newsline
Osteoporosis is the bane of many postmenopausal women's lives, with such unpleasant consequences as dowager's hump, spinal compression, and?-most feared of all?-hip fracture. So it is good news indeed that a new therapy?-a once-a-year infusion of zoledronic acid?-proves to significantly reduce fracture risk over a 3-year study period.1
Oral bisphosphonates currently in use have been shown to inhibit osteoclast-mediated bone resorption and reduce fracture risk. But many women find the dosing regimen these drugs require onerous, even with newer once-a-week and once-a-month versions, and adherence is poor. If a bisphosphonate regimen could be devised that was more acceptable, however, more women might make use of it?-provided it could be shown to be equally effective. A once-a-year infusion might fill that bill.
To test the effectiveness of this new therapy, investigators conducted a trial with 7765 postmenopausal women (average age 73), randomly assigning participants to receive a placebo or a single, 15-minute IV infusion of 5 mg of zoledronic acid at the outset of the study, at 1 year, and at 2 years (3876 subjects). This was the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly Pivotal Fracture (HORIZON) trial. In addition, all subjects received oral daily calcium, 1000-1500 mg, and vitamin D, 400-1200 IU. At the end of a 36-month follow-up period, the researchers found that, compared to placebo, the zoledronic acid infusion reduced the risk of vertebral fraction by 70% and of hip fracture by 41%. Bone mineral density and bone metabolism markers were significantly improved. Adverse events were similar in the 2 groups, with the exception of increased occurrence in serious atrial fibrillation (AF) in the zoledronic acid group (50 versus 20 patients).
An editorial accompanying the study calls the efficacy data from the HORIZON study "impressive."2 The reported higher incidence of AF is a concern, however; further studies on the safety of this procedure are ongoing. An association between bisphosphonates and osteonecrosis of the jaw, mainly but not entirely in cancer patients taking high doses, had caused anxiety and led to some change in prescribing practices. In the HORIZON study, 2 cases of osteonecrosis were reported, 1 in a study subject and 1 in the placebo group. Still to be determined is whether annual IV infusions will prove practical and acceptable by large numbers of women.
1. Black DM, Delmas PD, Eastell R, et al, for the HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007;356(18):1809-1822.
2. Compston J. Treatments for osteoporosis-looking beyond the HORIZON [editorial]. N Engl J Med. 2007;356(18):1878-1880.
Patient Care
I suppose a once a year infusion might be an improvement for a senior who has a hard time with pills. Most active women don't mind taking a pill once a week.
I am 50 and have been taking once a week actonel for 4 years and still my bone density went lower. My main concern isn't whether I can take a drug once a year, or once a week or even every day. My main concern is whether the drug can actually increase my bone density without the risk of cancer or building unhealthy bone?
There are a lot of misconceptions out there. For example Flouride makes for denser bone....but it's more brittle and more likely to fracture.
Do you also do "weight-bearing" excercises?
Forgot to add, another important variable is your intake of vitamin D. It's now recommended that women take in about 1000 mg/day of vitamtin D.
Also, at your yearly physical, your blood level of vitamin D should be measured to be sure you're getting enough of this vitamin.
Yes, of course I do those things and have been for about 20 years.
When I got my first BMD test at age 40 I was diagnosed with osteoporosis then. A specialist told me that this low BMD reading was probably the peak bone density that I reached in my prime. It's not that I had been losing bone density to get to that low level. It's just that was my peak.
I became menopausal at age 42. I maintained my BMD level until this year now (10 years later). Now my readings are down to -2.9 . Actonel has not increased my bone density, my BMD has decreased.
I would be interested to know if any treatment ever increases BMD one whole SD level? Are there any cases of a woman going from Z score of -3.0 up to BMD Z score of 0.0 ???? Can we increase our BMD higher than it was at our peak BMD ????
In some cases, I think it would be possible. In your specific case, all things considered, I don't think so.
I forgot to add, the dosage of vitamin D should be 1000 units/day not 1000 mg/day...my mistake.
@Miller,
All my blood tests and things have always shown my vitamin D levels to be normal. I also live in a sunny climate. One naturalist doctor told me to take 1000 units of Vit D, so I have been doing that for a while. The thing is that I think the BMD tests are a rather new thing .....BMD wasn't tested 40 or 50 years ago, right? What I wonder is if the evaluation of what is considered normal or what is considered to be osteoporosis is accurate? I was already diagnosed with osteoporosis BEFORE menopause. I've sought out many doctors and seen a bone specialist years ago. That specialist told me that it's most likely my BMD level at my very first reading BEFORE menopause was my normal peak bone mass, although it showed osteoporosis. He said that bone structure and flexiblity is more important than the density. He did say he thought in menopause I should take some drug. So once in menopause I was on Actonel for 3 years.....my BMD didn't decrease or increase for about 3 years, then when it went a fraction lower on one of the measures my doctor told me to go on Forteo.
I'm on Forteo now and that makes my joints feel achy and weak. Although it's hard to say if that is just the aging process or the effect of Foreto. I just think osteoporosis treatment is in the experimental stage because no one really knows if the meds are making that much of a difference. How can one say if a person would have gotten a fracture on or off the med?
I've never had a fracture, and never lost height, I don't have a hump. I'm just 50 years old but I'm on Forteo and wonder if it's going to give me cancer!
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