Osteoporosis is a common disorder among postmenopausal women which results in an increased risk of fractures. While several therapies improve bone strength and reduce the risk of spine and hip fracture, there is no cure for osteoporosis, and long-term treatment is needed. An upcoming presentation at The North American Menopause Society (NAMS) Annual Meeting in Philadelphia October 11-14 is scheduled to present new evidence about the long-term effectiveness and safety of treatment with bisphosphonates and denosumab.
This study — the largest to assess fracture risk in older, female, long-term bisphosphonate users — supports discontinuing therapy after 2 to 5 years & whether and when to restart bisphosphonate therapy after a drug holiday depends on which agent has been used and the patient’s underlying fracture risk.
Four important recommendations for duration of treatment for osteoporosis are-
1.Protection from fractures lasts as long as therapy with Bisphosphonates and denosumab is continued.
2. The concept of a “bisphosphonate holiday is confusing therefore a patient’s risk of fracture should be reevaluated after three to five years of bisphosphonate treatment.
3. The concept of a “holiday” from therapy applies only to the bisphosphonates and not to raloxifene, teriparatide, and denosumab.
4. It is necessary to have a long-term treatment plan for postmenopausal women with osteoporosis if the benefits of our therapies are to be realized on the pattern of lifelong treatment of hypertension or diabetes
Bisphosphonates and denosumab are the most commonly prescribed treatments for osteoporosis. Protection from fractures occurs within the first few months of treatment and persists as long as treatment is continued. Upon stopping bisphosphonate therapy, protection from fractures is gradually lost over three to five years. Treatment for more than three years has been associated with an increasing risk of unusual or “atypical” fractures of the femur (thigh bone). After five years of treatment, the risk of these atypical fractures is about 20 per 100,000 patients and increases to about 1/1,000 patients after eight to ten years of treatment.
The combination of increased risk of atypical fracture along with a relatively slow offset of the protection from fractures due to osteoporosis led to the confusing concept of a “bisphosphonate holiday.” The American Society for Bone and Mineral Research has recently provided clear recommendations about “bisphosphonate holidays.” After three to five years of bisphosphonate treatment, a patient’s risk of fracture should be reevaluated. For patients remaining at high risk of fracture (those with previous hip, spine, or multiple other fractures or with bone density values remaining in the osteoporosis range), continuing treatment or changing to a different drug like denosumab is important. For patients whose risk of fracture is lower, stopping treatment for two to three years (the “holiday”) can be considered but is not mandatory.
It’s important to note that the concept of a “holiday” from therapy applies only to the bisphosphonates and not to any of the other drugs used to treat osteoporosis. The beneficial effects of these other medicines, including raloxifene, teriparatide, and denosumab, are lost quickly when treatment is stopped.
“Because protection from fractures disappears quickly if denosumab treatment is stopped, and since there are no currently known safety issues that limit the duration of denosumab therapy, there is no justification for a drug holiday with this treatment,” says Dr. Michael McClung of the Oregon Osteoporosis Center in Portland, Oregon, who will be presenting his recommendations on long-term osteoporosis therapy at the NAMS Annual Meeting. “Just as we do not recommend stopping treatment for high blood pressure or diabetes, it is necessary to have a long-term treatment plan for postmenopausal women with osteoporosis if the benefits of our therapies are to be realized.”
“Prevention of osteoporosis should be a goal for those treating menopausal women, as up to 20% of bone loss occurs within the first five years of menopause. Once diagnosed with osteoporosis, the goal becomes lowering the risk of fractures as fractures can be life changing or life limiting. This presentation will offer valuable insights about the need for long-term treatment and will change the way health care providers approach long-term osteoporosis management,” says Dr. JoAnn Pinkerton, NAMS executive director.