Three osteoporosis treatment studies
Ten-year results of treatment with alendronate (Fosamax). This study reports the results of ten years of experience with alendronate on postmenopausal women. See N Engl J Med. 2004 Mar. 18;350(12):1189-99, Bone HG and others, PMID: 15028823. Women treated for ten years with 10-mg Fosamax had mean increases in bone mineral density (BMD) of 13.7% at the lumbar spine, 10.3% at the trochanter, and 5.4% at the femoral neck as compared with baseline values. The authors concluded: "The therapeutic effects of alendronate were sustained, and the drug was well tolerated over a 10-year period. The discontinuation of alendronate resulted in the gradual loss of its effects." Editor's comments: These results are good news, especially the safety element, but also the effectiveness. My most recent DXA showed comparable, or even better results in my own case over about the last eight years since I started taking Fosamax. My L1-L4 spine T-score is now -0.48 and my left femoral neck T-score is -0.77. The previous scores from the test done 4/27/2001 were -0.76 and -1.31 for the spine and hip, respectively. Thus, my hip and spinal BMD are back in the normal range. My physician has recommended going on 35-mg once-weekly Fosamax as a maintenance dose. I'll update this site with the next DXA to see how the maintenance dose is working.
Fracture risk comparing risedronate (Actonel), alendronate and nasal calcitonin (Miacalcin). See J Manag Care Pharm. 2004 Mar-Apr;10(2):142-51, Watts NB and others, PMID: 15032563. This is an interesting study with an unusual protocol in that it used a proprietary claims database which identified people who were newly prescribed one of the previously mentioned osteoporosis medications. Then they were followed up at six-month and one-year intervals for the incidence of nonvertebral fractures (clavicle, humerus, wrist, pelvis, hip and leg). There were large numbers of patients in the study with 774, 5,307 and 1,000 receiving calcitonin, alendronate and risedronate respectively and 93% were women. See the PubMed abstract for the details of the fracture reductions in each category. The important finding was that, compared to the other two medications, risedronate was significantly more effective at reducing nonvertebral fractures in the study population over the one-year period. These findings are similar to what has been shown in the clinical trials on risedronate, too. Editor's comments: Men with osteoporosis and at high risk for fracture should consider these results and discuss them with their physician when deciding which medication to use. Remember that teriparatide (human parathyroid, Forteo) was not considered in this study. As mentioned many times on this Website, this new treatment is a very effective means of building BMD and reducing fracture risk and should be considered, especially for severe loss of BMD. Also, note that vertebral fractures weren't included in this study, so you'll have to guess whether or not they would be similarly reduced with the risedronate. Sometimes the more options that are available, the harder is the choice of which medication to use. But, the bottom line for treatment isn't really increased BMD, although that is important, it is reduced fracture risk. So don't lose sight of that important reason for treatment.
Starting teriparatide after other medications have been used to treat osteoporosis. See J Bone Miner Res. 2004 May;19(5):745-51, Ettinger B and others. PMID: 15068497. Since many of us might have been treated with Fosamax or Actonel before starting teriparatide therapy, this study has important implications as to what to expect for results. Remember that the bisphosphonates have a very long half-life, so they are incorporated into the bone preventing break down for a long time once ingested. Teriparatide works by stimulating bone growth, so you might expect it to be less effective in the presence of a bisphosphonate, and that is what this study found. The authors also looked at women who had taken raloxifene, but I won't consider those results since they don't apply to men. In this 18-month study 59 post menopausal women were given daily subcutaneous injections of 20-microg teriparatide daily. They also took 1000 mg calcium and 400 IU vitamin D in supplements. The researchers evaluated changes in BMD via DXA and looked at changes in bone turnover markers. The findings showed that pretreatment with alendronate prevented increases in BMD, especially in the first six months. But, the results weren't really too spectacular in the alendronate group at any time period during the 18-month study. Bone density increased more than double in the spine in the raloxifene pretreatment group compared to the alendronate group. So, this means if you aren't getting adequate results with a bisphosphonate and your physician switches you to Forteo, don't expect the same great results that most people get if teriparatide is used as a first-line osteoporosis treatment, especially early in treatment.