We appreciate the opportunity to express our views on the U.S. Preventive Services Task Force (USPSTF) draft recommendations and evidence review on Screening for Osteoporosis to Prevent Fractures. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.
We support the efforts of the U.S. Preventive Services Task Force to re-evaluate the benefits and harms of osteoporosis screening in adults in the context of fracture prevention, which is a more meaningful outcome than bone mineral density. In light of research studies which focus on risk calculation tools and the risk/benefit profile of drug treatments, we agree with a focused screening recommendation in postmenopausal women aged 65 and older. We agree that risk calculators can help guide decision-making in younger postmenopausal women. We also believe that the evidence for or against screening in men is lacking, and therefore decisions are best left up to the individual and provider.
However, we strongly disagree with the conclusion that screening deserves a grade of “B” and we offer the following specific concerns and suggestions:
#1. The USPSTF found no substantial evidence that directly supports that screening prevents fractures, and adding “to prevent osteoporotic fractures” implies that screening leads to that outcome without specifying which treatments or interventions are effective. There are potential benefits gained through proper diagnosis, but unfortunately the research review does not offer a review of which treatments or interventions have benefits that outweigh the potential risks and for which women. It is especially unfortunate that the review does not include any non-pharmacological treatments, given that drug treatments have the least evidence of benefit, but are the most likely to be implemented.
#2. We agree with the separate grading and recommendation for younger women and the inclusion of the term “postmenopausal.” In addition, we suggest adding a distinct recommendation for younger pre-menopausal women (we suggest a grade “D”) to make it very clear that there is no evidence that pre-menopausal women will benefit from screening.
#3. We agree with the inclusion of KQ1 (screening benefits) and KQ3 (screening harms) in the evidence review, and agree that there is not substantial evidence supporting the direct benefits or harms of screening. However, two studies which did not meet inclusion criteria (Cardiovascular Health Study and the SCOOP study) demonstrate mixed results that warrant further examination. The nested Cardiovascular Health Study found a significant 36% relative reduction in hip fractures over about 5 years in those who got screened. Likewise, the preliminary results of the SCOOP trial found a 27% relative reduction in hip fractures over 5 years in screened women. Unfortunately, there is no data indicating why the screening was associated with fewer fractures and SCOOP concluded that screening made no difference in overall fracture risk, death, or quality of life. While it is encouraging that the two studies demonstrate reduced hip fracture risk, it is worth noting that the screening program did not achieve other intended health outcomes, such as reducing overall fractures or deaths. We strongly suggest that these issues be examined in greater detail before USPSTF finalizes their recommendations and immediately revise them if later research provides additional information.
#4. We appreciate the comprehensive review of the benefits and harms of drug treatments for osteoporosis. However, we strongly disagree that the harms are “no greater than small”; this conclusion is inaccurate and misleading. For example, the FDA warns women that hormone therapy can increase the risk of serious diseases, including “blood clots, heart attacks, strokes, breast cancer, and gallbladder disease and that “for a woman with a uterus, estrogen increases the chance of getting endometrial cancer.1”
Bisphosphonates are the most common drug treatment and there is no evidence that they prevent hip fractures, while there is clear evidence that they cause other serious fractures and jaw conditions. This lack of benefit for preventing hip fracture is a significant shortcoming because hip fractures are the fracture of greatest risk to older women, too frequently causing disability or death. In addition, there is no evidence that any benefits of taking bisphosphonates for more than 5 years outweigh the risks. In fact, more evidence of harms have come to light, including the FDA’s 2011 warning on Reclast’s harmful effects on the kidney2. Therefore, we strongly urge changing the description of harms to “moderate” or “moderate to severe” and pointing out the lack of clear evidence that the benefits of these prescription drugs outweigh the risks for many women.
#5. We suggest exploring other potential benefits (and harms) of screening outside of the scope of drug treatments. We suggest reviewing the evidence for non-drug therapies, such as a calcium/vitamin D enriched diet, calcium and vitamin D supplements, and weight-bearing exercise. USPSTF has investigated dietary supplements and exercise for preventing fractures and falls, and they are clearly at least as relevant to recommendations regarding screening. Reviewing the evidence for non-pharmacological treatments as part of the recommendations regarding screening will help women and doctors identify more global benefits of screening for osteoporosis and osteopenia. The USPSTF should include in their research whether women who screen positive for osteoporosis/osteopenia adopt positive health behaviors, and whether those behaviors lead to reduced fracture risk and better health outcomes. We strongly urge that these issues be assessed before USPSTF finalizes their recommendations.
In conclusion, we strongly suggest the USPSTF provide a separate and clear “D” recommendation against screening in premenopausal women younger than 65. We strongly recommend that the USPSTF not finalize its recommendations until further information is made available regarding the direct benefits and harms of screening as noted above. In addition, we strongly urge that the evidence supports that the harms of drug therapies are “moderate” or “moderate to severe” and these risks be compared to the lack of evidence that these drugs reduce hip fractures, rather than concluding that the benefits are substantial and the risks are “no greater than small.” Last, we urge that USPSTF examine the benefits and harms of non-drug therapies as part of its screening recommendations.
We appreciate your careful review of our recommendations as outlined above.
For questions or comments please contact Dr. Diana Zuckerman, PhD, at dz@center4research.org
References:
- U.S. FDA. Consumer Information for Women. Menopause and Hormones: Common Questions. Updated June 2017. Available online: https://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118624.htm
- U.S. FDA. FDA Drug Safety Communication: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid). September 2011. Available online: https://www.fda.gov/Drugs/DrugSafety/ucm270199.htm