My wife is in her 70s. Her doctor checks the “density” of her bones** every few years and her bones are slowly getting “thinner.” When she reaches her 80s she will likely need to go beyond diet, exercise, and pills that contain vitamin D, magnesium and calcium—and she will have to start taking biphosphonates. Some of her friends have long taken medications like aledronate, drugs that slow bone “resorption.”

In 2019 the FDA approved a medication that more effectively combats osteoporosis. It’s an antibody that promotes the formation of new normal bone-- and is called Romosozumab—brand name Evenity. Many hope it will have a major impact on the problem. As of now we aren’t sure how risky the drug is. The package insert contains a black box warning that says the drug “may increase the risk of myocardial infarction, stroke and cardiovascular death.” The words of caution are based on one of two studies of people who were treated.* Currently, the medication is mainly used to treat some who have severe osteoporosis, and experts are carefully watching and evaluating.

Since osteoporosis is not my field, the opinions that follow are taken from two interviews given by Clifford Rosen an M.D who spent his life researching and treating osteoporosis.

In his 2019 interview with Dianne Atwood he defined osteoporosis as a condition of low quality, weaker bones. There is a micro-deterioration of the inner structures –the trabeculae or struts of the skeleton. The disease is “silent.” People with the condition don’t know their bones are worsening until they have a fracture, but doctors can catch the problem early by performing bone density tests.

Rosen: Bone mass peaks in girls who are 13 to 15 years old and boys who are 15 to 20. Bone cells are more energetic when people are young. 10 percent of our skeleton turns over each year, and bone is always remodeling. As we age we tend to lose more bone than we gain. The longer we live the more bone we need in the bank so we will have enough reserve when we start losing it.
To keep our bones going, we need an adequate amount of calcium to lay down bone.. like (he said) 500mg a day. A glass of milk contains 300mg. Vitamin D increases absorption of calcium in the gut four fold. He believes 600 to 800 units of vitamin D and 15 minutes daily in the sun is all we need. Exercise may slow bone loss but it doesn’t really cause bone mass to increase in people older than 10.
Osteoporosis is more common in people who are obese and those who are very thin as well as individuals with gluten enteropathy. The rate of bone deterioration increases after menopause. Astronauts who spend a lot of time in space develop osteoporosis and we don’t know how to prevent or treat their problem.
In the 1990s doctors were monitoring 50 year olds and some doctors treated young women early and for a long time. A very small number of the women developed a devastating atypical fracture of the upper femur, and their plight had a bad effect on the psyche of many.

Currently the public health service recommends starting monitoring at age 65 with bone density scans. We are asked to consider treating based on bone density and an age based algorithm. Medications are recommended:

If our algorithm suggests a person has a 20 percent risk of having an osteoporotic fracture in the next 10 years, and/or.

If it suggests a 3 percent risk of having hip fracture within 10 years

Rosen said that in a person who is“just” osteoporotic the risk of jaw problems (an area of dead jaw bone) is in the one in hundred thousand range, even with dental surgery. The complication is devastating when it occurs and may be partly caused by an infection or poor blood flow

Aledronate “induced” painful and sometimes devastating fractures of the upper femur—atypical fractures-- are unusual and are mainly seen in young people who took biphosphanates for a long time.

Rosen currently likes to treat women with significant osteoporosis with once a week albendazole. He continues the drug for three years-- then he tests. If the bone density has improved he suggests a two to five year drug holiday. The medication is present in the body for a long time. At the end of the holiday Rosen resumes the medication.
He doesn’t recommend a holiday if a person is taking denosumab. (That drug is an injection that prevents bone loss by blocking a certain receptor in the body.) When denosumab is stopped, bones get worse rather quickly..

And yes, in people with severe osteoporosis Rosen does use Romosozumab. He gives it once a month for a year and it is quite effective. The drug is an antibody that works by blocking a genetically induced peptide called sclerostin. Sclerostin is produced by osteocytes, bone cells, and it performs a vital function. We turn over 10 percent of our bone tissue each year and the peptide prevents our bodies from creating too much bone. (Sclerostin was first described in 1955 by a Netherlands physician. He told of two brothers who had a rare recessive lifelong condition. They made too much sclerostin and “produced bone faster than the body broke it down. As a result their bones became thicker as they aged.” The bony overgrowth led to pinched nerves.)

How good and bad is Romosozumab?

*The ARCH study (Active-Controlled Fracture Study) in Postmenopausal Women with Osteoporosis at High Risk) enrolled 4093 postmenopausal women,

2046 received monthly subcutaneous Romosozumab (210 mg) for 12 months. Then they took alendronate for 12 months.

2047 received weekly oral alendronate (70 mg) alone for 24 months.

In people on Romsumab there was a 48% lower risk of new vertebral fracture, a 38% lower risk of hip fracture, and 19% lower risk of nonvertebral fracture.

However, during the first year, the incidence of cardiac ischemic events and cerebrovascular events was higher in the Romosozumab group. (0.8% versus 0.3%).

Additionally, in the first 12 months the incidence of adjudicated serious cardiovascular events was higher in the Romosozumab than the alendronate group. (2.5% versus 1.9%),

During the second 12 months, after all patients were placed on alendronate, and there was no difference in the incidence of coronary disease. (6.5% versus 6.1%).

**“The amount of radiation used during a bone density scan is less than 2 days exposure to naturally occurring minerals in the ground, water plus radiation from our own bodies and a bit of cosmic radiation from space”

https://asbmr.onlinelibrary.wiley.com/doi/pdf/10.1002/jbmr.3996

https://resident360.nejm.org/curbside-consults/osteoporosis-with-dr-clifford-j-rosen

https://www.nytimes.com/2019/04/09/health/osteoporosis-evenity-bone-amgen.html

https://www.facebook.com/MaineMedicalCenter/posts/concerned-about-osteoporosis-cliff-rosen-md-of-the-maine-medical-center-research/10157231615544383/