Professional Statements and Societal Positions Guidelines
Practice Guidelines and Position Statements
The Endocrine Society
The 2019 guidelines from the Endocrine Society recommend that in postmenopausal women with a low BMD and at high-risk of fractures who are being treated for osteoporosis, monitoring should be conducted by dual-energy X-ray absorptiometry at the spine and hip every 1 to 3 years. The Society considers measuring bone turnover markers (serum CTX for antiresorptive therapy or P1NP for bone anabolic therapy) as an alternative way of monitoring for poor response or non-adherence to therapy. The society notes that there is uncertainty over what constitutes an optimal response to treatment, but some experts suggest that a meaningful change is approximately 40% when compared from before to three (3) to six (6) months after starting treatment.
The American Association of Clinical Endocrinologists and the American College of Endocrinology
The 2016 guidelines from the American Association of Clinical Endocrinologists and the American College of Endocrinology (AACE/ACE) gave a Grade B recommendation to consider using bone turnover markers for assessing individual compliance and therapy efficacy. AACE/ACE reviewed evidence that markers respond quickly to therapeutic intervention, and changes in markers have been associated with bone response to therapy and fracture risk reduction (level 1 RCT) supporting their use in clinical trials. However, the guidelines note that use in clinical practice is "limited by high in vivo and assay variability, poor predictive ability in individual individuals, and lack of evidence-based thresholds for clinical decision-making."
National Osteoporosis Foundation
In 2014, the National Osteoporosis Foundation published its guidelines on the prevention and treatment of osteoporosis to prevent fractures. Regarding biochemical markers of bone turnover, the guidelines stated:
“Biochemical markers of bone turnover can
- aid in risk assessment and serve as an additional monitoring tool when treatment is initiated
- be repeated to determine if treatment is producing expected effect. "
"Biochemical markers of bone turnover may
- Predict rapidity of bone loss in untreated individuals
- Predict extent of fracture risk reduction when repeated after three to six (3 to 6) months of treatment with FDA [Food and Drug Administration]-approved therapies
- Predict magnitude of BMD [bone mineral density] increases with FDA-approved therapies
- Help determine adequacy of individual compliance and persistence with osteoporosis therapy
- Help determine duration of ‘drug holiday’ and when and if medication should be restarted (Data are quite limited to support this use, but studies are underway.)”
North American Menopause Society
The North American Menopause Society (2010) provided a position statement on the management of osteoporosis in postmenopausal women. The statement included a recommendation that “the routine use of biochemical markers of bone turnover in clinical practice is not generally recommended.”
International Society for Clinical Densitometry
In 2011, a joint statement by the International Society for Clinical Densitometry and the International Osteoporosis Foundation on the Fracture Risk Assessment Model (FRAX) fracture risk prediction algorithms indicated that the “Evidence that bone turnover markers predict fracture risk independent of BMD [bone mineral density] is inconclusive. Therefore, bone turnover markers are not included as risk factors in FRAX.”
National Bone Health Alliance
Recommendations from the National Bone Health Alliance (2017) considered N-terminal propeptide of type I procollagen (PINP) and C-terminal telopeptide of type I collagen (CTX-I) as “international reference standards” for bone formation and resorption, respectively. Among the conditions associated with increased bone turnover were primary hyperparathyroidism, vitamin D deficiency, immobility, fracture, and Paget disease; the guidelines also considered diseases associated with low or disassociated bone turnover. The National Bone Health Alliance advised that caregivers control for factors such as food intake, time of sample collection, and handling procedure (i.e., CTX-I assays should be conducted in a fasting state); and that those interpreting the results of bone turnover marker tests be familiar with how uncontrollable factors (i.e age, comorbidities, medications) may interact with an individual’s CTX-I or PINP levels.
U.S. Preventive Services Task Force Recommendations
The U.S. Preventive Services Task Force (2018) recommended screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in women 65 years and older. The Task Force recommended screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in postmenopausal women younger than 65 years who are at increased risk of osteoporosis, as determined by a formal clinical risk assessment tool. The recommendations on osteoporosis screening addressed dual-energy x-ray absorptiometry testing but did not mention bone turnover markers.