Prolia, Now Approved for Male Osteoporosis
Amgen recently approved Prolia® (denosumab) for the treatment of male osteoporosis. This medication’s approval for women occurred in June 2010 for patients at high risk for fracture. High risk patients are those with a history of fractures, multiple risk factors or patients who are intolerant to other osteoporosis medications.
Due to the screening process, patients need to be checked for hypocalcemia, since this drug can exacerbate pre-existing low blood calcium levels if this medication is taken for the treatment of osteoporosis. Also, this is one of the drugs that are not approved for those with osteopenia. Low T-Scores are needed to meet the qualifications for this medication.
This drug is given via injection, in a doctor’s office or out-patient clinic, twice yearly. It is not an infusion, like Reclast, so the process is pretty straight forward with a single subqutaneous injection in the thigh, arm, or abdomen of 60 milligrams per injection.
There has been some concern about osteonecrosis of the jaw (ONJ), with this medication, if it is given for prolonged periods. General warnings regarding osteonecrosis are for those contemplating tooth extractions, dental implant or any invasive dental procedure involving the jaw bone. If you are considering the above procedures after Prolia treatment, please discuss these issues with your oral surgeon.
Mineral metabolism problems should be corrected before Prolia can be administered. Total serum calcium and Vitamin D tests (25 (OH) D) should be performed and patients should be in the normal range, or have levels corrected to normal before the treatment.
Common Side Effects:
- Back Pain
- Extremity Pain
- Musculoskeletal Pain
Adverse Side Effects:
- Hypocalcemia (in 1.7% of Prolia group)
- Serious Infections (in 3.3% of placebo group and 4.0% in the Prolia group)
- Dermatological adverse reactions (in 8.2% in placebo and 10.8% in the Prolia group)
- Osteonecrosis of the jaw
- Pancreatitis (in 0.8% of the Prolia group)
Advantages of this Treatment:
All of the oral osteoporosis treatments are available in daily, weekly, bi-monthly, and monthly regimes, so this twice yearly injectable treatment makes the process easier to handle and helps to keep patients compliant, which is one of the biggest obstacles within osteoporosis treatment. Many patients will start a medication but few continue on the schedule as prescribed, which most likely is due to the postural, food withholding and gastrointestinal upset seen with many of these oral preparations.
Prolia produced increased bone mineral density at three years of treatment of 8.8% at the lumbar spine, 6.4% total hip, and 5.2% at the femoral neck. “Prolia was effective in reducing the risk for new morphometric vertebral fractures regardless of age, baseline rat of bone turnover, baseline BMD, baseline history of fracture, or prior use of a drug for osteoporosis (Prolia Prescribing Information-Amgen, June 2, 2010).” These figures are based on a study that included women.
If you are considering this type of treatment, Amgen has started “The Prolia Post-marketing Active Safety Surveillance Program which is available to collect information from the prescribers on specific adverse events. For more information see http://www.proliasafety.com/ or call -800-772-6436 for information about this program (Prolia Prescribing Information, June 2, 2010).”
Prolia also has a shorter half-life, compared to the bisphosphonates at a mean half-life of 25.4 days.
Patients receiving Xgeva (denosumab), cannot take Prolia.
The approximate cost is $825.00 per injection.
How Prolia Works:
“Prolia (denosumab) is the first FDA-approved RANK Ligand inhibitor. Prolia targets and binds to RANK Ligand, inhibiting osteoclast formation, function and survival. Thus, Prolia can help keep osteoclasts from resorbing bone.”
- Prolia Prescribing Information, 2010 June 2; 1-30. http://pi.amgen.com/united_states/prolia/prolia_pi.pdf
- Am Fam Physician. 2002 Jul 1; 66(1):119-24. http://www.ncbi.nlm.nih.gov/pubmed/12126026?dopt=Abstract#