Menopausal HT may help protect against development of age-related stooped posture

A new North American study found that women who are continuous or remote users menopausal hormone therapy have less evident kyphosis in their mid-eighties as compared to never users. The study is published ahead of print on February 16, 2018, in menopausal society journal Menopause.

Age-related hyperkyphosis is exaggerated anterior curvature of the spine is common in men and post-menopausal women and is associated with increased bone loss, degenerative disc diseases, and vertical compression fractures. It causes difficulty in performing activities of daily living and reduces the quality of life.

The Women’s Health Initiative study has also shown that hormone therapy (HT) reduces the odds of vertebral fractures. Based on the same hypothesis, this study also confirmed the protective effect of HT against the development of kyphosis or dowager’s hump.

The significant decline in estrogen levels after menopause results in accelerated bone loss resulting in the compression fracture of the vertebra. After a woman is put on HT, bone loss increases steadily in 3 years and is maintained by continuous use.

The authors of this study looked at data from nearly 10,000, community-dwelling women aged 65 and older from the landmark Study of Osteoporotic Fractures (SOF) and followed them for a period of 15 years. This study is a multicentric, observational study started in 1986 and closed after 31 years in September 2017.

Kyphosis was measured by mapping the Cobb angle in lateral radiograph spine and correlated with HT use.

The mean age of study participants was 83.7 ± 3.3 years and a mean Cobb angle of 51.3 ± 14.6°. 

Nearly half of the women reported having never used HRT, while 25% reported using it remotely in past, 17% reported that they used HT intermittently while only 12% reported continuous use.

After accounting for confounders, women who used HT in remote past and continuous users had nearly 3.0° less kyphosis compared with never users. Intermittent use did not confer any protection and the women had the same Cobb angle as never users.

The SOF findings also showed that women who lose more than two inches in height have an increased risk for fracture and early death.

NAMS executive director Dr. JoAnn Pinkerton concluded, “Women who reported the early use of HT were less likely to develop age-related kyphosis, and the protective benefits continued even after stopping HT. This supports a benefit of prescribing HT close to menopause.”

Abstract

NAMS press release

FDA approves Abaloparatide, the first anabolic treatment for postmenopausal osteoporosis.

Courtesy: Radius Health 

The US Food and Drug Administration (FDA) approved abaloparatide injections for treatment of postmenopausal women who are at high risk for developing osteoporosis. It is marketed under brand name TYMLOS.

It is the first anabolic treatment approved for women at risk of osteoporosis in last 15 years said the company Radius Health.

1. It is indicated in women with history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
2. The recommended daily dose of Tymlos is 80 mcg subcutaneously into the periumbilical region of the abdomen.
3. Women should supplement the diet with Calcium and Vitamin D.
4. Its use in combination with parathyroid hormone for more than 2 years is not recommended.  
5. It is available as prefilled pen with 30 doses of the drug as sterile, clear, colorless solution.

The clearance of abaloparatide was based on the positive results of a phase 3, multicentric, randomized, double-blind, placebo controlled trial called as Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) trial and also ACTIVExtendTrial.

 The ACTIVE trial recruited nearly 2500 women postmenopausal women with osteoporosis aged 49 to 86 years (mean age 69 years) who were randomized to receive 80 mcg of TYMLOS (N = 824) or placebo (N = 821), given subcutaneously once daily for 18 months.

The ACTIVE trial showed that patients on abaloparatide had 86% reduced risk of new vertebral fractures and 43% reduction for nonvertebral fractures. The absolute risk reduction was 3.6% and 2.01% respectively.

The paper was published in April 2016 issue of JAMA.

The ACTIVExtend Trial is an extension of the previous trial recruited patients who has already completed 18 months of subcutaneous abaloparatide or placebo. They received up to 24 additional months of alendronate; there was 1 month between the studies to re-consent patients.

The study results published in Mayo Clinic Proceedings showed improvement in bone mineral density and reduced fracture risk throughout the skeleton.

The label on abaloparatide shows a boxed warning about a dose-dependent increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80-mcg dose. It is unknown if abaloparatide will cause osteosarcoma in humans.

It is contraindicated in patients at increased risk of for osteosarcoma and its cumulative use with parathyroid hormone analogs (eg, teriparatide) for more than 2 years during a patient's lifetime is not recommended.

John Bilezikian, MD, director of the metabolic bone diseases program at Columbia University Medical Center in New York City, said in a company news release "Provides physicians a new treatment option for postmenopausal women with osteoporosis which could help to rapidly, consistently and significantly increase bone mineral density and reduce their risk of fractures. Fragility fractures should be viewed as sentinel events which require urgent evaluation and treatment because after that first fragility fracture, patients are at greater risk for subsequent fractures. The FDA's approval of Tymlos represents an important step in our ability to treat this serious and complex disease and, in the process, address this urgent public health crisis."