What We Don’t Know About Osteoporosis Treatment

A 5-member panel of experts in primary care, geriatrics, and behavioral sciences, among others, convened by the  National Institutes of Health (NIH), sought to answer that question. In the Pathways to Prevention (P2P) Workshop: Appropriate Use of Drug Therapies for Osteoporotic Fracture Prevention, the panel discussed the available evidence on long-term drug therapies, in hopes of identifying research gaps and ways to “advance the field.” Then they published a report that summarizes their findings, along with recommendations for “new strengthened research.”

Trials have found 3 to 5 years of ODT is safe and effective, the panel notes, and that some ODTs reduce the incidence of nonvertebral fractures. But those studies have been done mainly in white postmenopausal women. Men, people of other race and ethnicity, residents in facilities, people with advanced and multiple comorbid conditions, and other populations are absent or underrepresented. Thus, estimates on benefits and harms may differ in practice. Moreover, the trial results presented no data on nonfracture patient outcomes or sequelae, such as mobility, hospitalizations, and nursing home placement. The studies also offered limited or no evidence on whether patient characteristics would result in different fracture outcomes.

The panel also noted that few trials extended beyond 5 years, although some observational studies provided “limited evidence” on potential benefits and harms from longer term use. Gaps exist in how to use information on bone biomarkers and other patient characteristics, such as concurrent medication use, that might modify the effects of ODT, the panel concluded.

 One of the main issues the panel investigated was how to make sure that the people at highest risk of fracture get the medicine they need. Only about one-third of women at high risk have reported treatment with osteoporosis medication. And among older adults with a hip fracture, only 11% to 13% filled any prescription for osteoporosis medication within 3 months of the fracture.

Information about ODT use and adherence was not included in the systematic evidence review, so the report relies on material provided by the workshop speakers, who say low rates of diagnosis and treatment probably stem from multiple clinician and patient factors. For instance, they said, with regard to clinicians, the problems may be lack of time, knowledge gaps, and lack of appropriate systems in primary care.

The panelists also cited another gap: in communication between clinicians about treatment as patients transition from one setting to another. One solution could be a hospital-based fracture liaison service to coordinate care, they suggest.

Patient factors include perceptions that osteoporosis is a normal part of aging, or that drugs do not work or that they are harmful and risky. Studies about decision making have found that people often overestimate their risk for rare adverse effects (AEs) and underestimate the likelihood of having a fracture.

In their assessment of studies, the workshop panelists found education-based interventions sometimes increase rates of filled prescriptions but not adherence 6 or 10 months down the road. They also found coaching and counseling have been “largely ineffective.”

“We need to identify the reasons why,” the panelists concluded, and made a number of recommendations about how to do the research. For instance, they suggest using a broader array of trial designs, such as innovative platform trials as used in cancer research, where the target of the investigation is the disease and not the drug. Studies also should focus on fracture sequelae, and include diverse populations that “more closely match” the characteristics of people who actually have fractures.

Gaps in knowledge about the uncommon AEs reported with bisphosphonates and other questions mean questions to be answered include which class of drugs should be used first, when treatment should start and how long it should last, and which doses are preferable.

Knowing how to treat can help clinicians and their patients decide whom to treat, the report suggests. Addressing the research gaps will improve the shared decision making needed for answering those questions.

The report was published in Annals of Internal Medicine on April 23, 2019.

A 5-member panel of experts in primary care, geriatrics, and behavioral sciences, among others, convened by the  National Institutes of Health (NIH), sought to answer that question. In the Pathways to Prevention (P2P) Workshop: Appropriate Use of Drug Therapies for Osteoporotic Fracture Prevention, the panel discussed the available evidence on long-term drug therapies, in hopes of identifying research gaps and ways to “advance the field.” Then they published a report that summarizes their findings, along with recommendations for “new strengthened research.”

Trials have found 3 to 5 years of ODT is safe and effective, the panel notes, and that some ODTs reduce the incidence of nonvertebral fractures. But those studies have been done mainly in white postmenopausal women. Men, people of other race and ethnicity, residents in facilities, people with advanced and multiple comorbid conditions, and other populations are absent or underrepresented. Thus, estimates on benefits and harms may differ in practice. Moreover, the trial results presented no data on nonfracture patient outcomes or sequelae, such as mobility, hospitalizations, and nursing home placement. The studies also offered limited or no evidence on whether patient characteristics would result in different fracture outcomes.

The panel also noted that few trials extended beyond 5 years, although some observational studies provided “limited evidence” on potential benefits and harms from longer term use. Gaps exist in how to use information on bone biomarkers and other patient characteristics, such as concurrent medication use, that might modify the effects of ODT, the panel concluded.

 One of the main issues the panel investigated was how to make sure that the people at highest risk of fracture get the medicine they need. Only about one-third of women at high risk have reported treatment with osteoporosis medication. And among older adults with a hip fracture, only 11% to 13% filled any prescription for osteoporosis medication within 3 months of the fracture.

Information about ODT use and adherence was not included in the systematic evidence review, so the report relies on material provided by the workshop speakers, who say low rates of diagnosis and treatment probably stem from multiple clinician and patient factors. For instance, they said, with regard to clinicians, the problems may be lack of time, knowledge gaps, and lack of appropriate systems in primary care.

The panelists also cited another gap: in communication between clinicians about treatment as patients transition from one setting to another. One solution could be a hospital-based fracture liaison service to coordinate care, they suggest.

Patient factors include perceptions that osteoporosis is a normal part of aging, or that drugs do not work or that they are harmful and risky. Studies about decision making have found that people often overestimate their risk for rare adverse effects (AEs) and underestimate the likelihood of having a fracture.

In their assessment of studies, the workshop panelists found education-based interventions sometimes increase rates of filled prescriptions but not adherence 6 or 10 months down the road. They also found coaching and counseling have been “largely ineffective.”

“We need to identify the reasons why,” the panelists concluded, and made a number of recommendations about how to do the research. For instance, they suggest using a broader array of trial designs, such as innovative platform trials as used in cancer research, where the target of the investigation is the disease and not the drug. Studies also should focus on fracture sequelae, and include diverse populations that “more closely match” the characteristics of people who actually have fractures.

Gaps in knowledge about the uncommon AEs reported with bisphosphonates and other questions mean questions to be answered include which class of drugs should be used first, when treatment should start and how long it should last, and which doses are preferable.

Knowing how to treat can help clinicians and their patients decide whom to treat, the report suggests. Addressing the research gaps will improve the shared decision making needed for answering those questions.

The report was published in Annals of Internal Medicine on April 23, 2019.

A 5-member panel of experts in primary care, geriatrics, and behavioral sciences, among others, convened by the  National Institutes of Health (NIH), sought to answer that question. In the Pathways to Prevention (P2P) Workshop: Appropriate Use of Drug Therapies for Osteoporotic Fracture Prevention, the panel discussed the available evidence on long-term drug therapies, in hopes of identifying research gaps and ways to “advance the field.” Then they published a report that summarizes their findings, along with recommendations for “new strengthened research.”

Trials have found 3 to 5 years of ODT is safe and effective, the panel notes, and that some ODTs reduce the incidence of nonvertebral fractures. But those studies have been done mainly in white postmenopausal women. Men, people of other race and ethnicity, residents in facilities, people with advanced and multiple comorbid conditions, and other populations are absent or underrepresented. Thus, estimates on benefits and harms may differ in practice. Moreover, the trial results presented no data on nonfracture patient outcomes or sequelae, such as mobility, hospitalizations, and nursing home placement. The studies also offered limited or no evidence on whether patient characteristics would result in different fracture outcomes.

The panel also noted that few trials extended beyond 5 years, although some observational studies provided “limited evidence” on potential benefits and harms from longer term use. Gaps exist in how to use information on bone biomarkers and other patient characteristics, such as concurrent medication use, that might modify the effects of ODT, the panel concluded.

 One of the main issues the panel investigated was how to make sure that the people at highest risk of fracture get the medicine they need. Only about one-third of women at high risk have reported treatment with osteoporosis medication. And among older adults with a hip fracture, only 11% to 13% filled any prescription for osteoporosis medication within 3 months of the fracture.

Information about ODT use and adherence was not included in the systematic evidence review, so the report relies on material provided by the workshop speakers, who say low rates of diagnosis and treatment probably stem from multiple clinician and patient factors. For instance, they said, with regard to clinicians, the problems may be lack of time, knowledge gaps, and lack of appropriate systems in primary care.

The panelists also cited another gap: in communication between clinicians about treatment as patients transition from one setting to another. One solution could be a hospital-based fracture liaison service to coordinate care, they suggest.

Patient factors include perceptions that osteoporosis is a normal part of aging, or that drugs do not work or that they are harmful and risky. Studies about decision making have found that people often overestimate their risk for rare adverse effects (AEs) and underestimate the likelihood of having a fracture.

In their assessment of studies, the workshop panelists found education-based interventions sometimes increase rates of filled prescriptions but not adherence 6 or 10 months down the road. They also found coaching and counseling have been “largely ineffective.”

“We need to identify the reasons why,” the panelists concluded, and made a number of recommendations about how to do the research. For instance, they suggest using a broader array of trial designs, such as innovative platform trials as used in cancer research, where the target of the investigation is the disease and not the drug. Studies also should focus on fracture sequelae, and include diverse populations that “more closely match” the characteristics of people who actually have fractures.

Gaps in knowledge about the uncommon AEs reported with bisphosphonates and other questions mean questions to be answered include which class of drugs should be used first, when treatment should start and how long it should last, and which doses are preferable.

Knowing how to treat can help clinicians and their patients decide whom to treat, the report suggests. Addressing the research gaps will improve the shared decision making needed for answering those questions.

The report was published in Annals of Internal Medicine on April 23, 2019.