Q: I have osteoporosis and was told by my local pharmasist that Fosamax should not be taken for longer than five years, according to the drug information. It accumulates in the bones and has no more effect after five years. Is this a true statement? I am also interested in Reclast. My osteoporosis is in my hips and lower spine. I understand that I am limited to Fosamax because the drug is specified for those areas. I was told I could not take Boniva due to the location of my osteoporosis.
A: According to the prescribing information given by the manufacturer, bisphosphonates such as Actonel (risedronate), Boniva (ibandronate), and Fosamax (Osteosan) are indicated for treatment of osteoporosis. The specific location of the osteoporosis is not specified. The manufacturers also support the use of bisphosphonates indefinitely to treat osteoporosis. Whether they should be used long-term is controversial. Some studies suggest long-term use of bisphosphonates (over five years) may have no additional benefits. It is even suggested that long-term used may cause an increase risk for femur fractures because bisphosphonates may overly decrease bone turnover rate. Other studies show long-term use of bisphosphonates does not cause an increased risk of femur fractures. Currently, the FDA is advising prescribers to continue following the guideline set by the manufacturers but be aware of the possible risk of femur fractures when used long term. The FDA is informing patients to report signs of hip pain when taking bisphosphonates. It is common practice for patients at low risk to take bisphosphonates for no more than five years. For those who are at high risk (very low bone density), indefinite use of bisphosphonates may be necessary. Reclast (//www.everydayhealth.com/drugs/reclast) is an injectable form of zoledronic acid (Zometa) used to prevent spinal and hip fractures. Clinical studies show Reclast can reduce spinal fractures by 70 percent and hip fractures by 41 percent. Reclast is certainly a good alternative to bisphosphonates and is more specific for osteoporosis in the hip and spine. The drawback may be cost. Please consult the prescriber before discontinuing or make any change to current therapy. For further information regarding osteoporosis, please visit //www.everydayhealth.com/osteoporosis/guide/ For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Lori Mendoza, PharmD
What Are Side Effects Associated with Using Osteosan?
Common side effects of Osteosan include:
Less common side effects of Osteosan include:
Serious side effects of Osteosan include:
- Severe pain (joints, bone, muscle, jaw, back or heartburn)
- Chest pain
- Difficulty swallowing
- Bloody stools
- Eye pain
- Skin blisters
- Swelling of the face, tongue, or throat
Postmarketing side effects of Osteosan reported include:
- Body as a whole: Hypersensitivity reactions including hives and skin swelling; transient muscle pain, feeling unwell (malaise), weakness/lack of energy, and fever; symptomatic hypocalcemia; swelling of extremities
- Gastrointestinal: Esophagitis, esophageal erosions, esophageal ulcers, esophageal stricture or perforation, and mouth or throat ulceration; gastric or duodenal ulcers
- Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing
- Musculoskeletal: Bone, joint, and/or muscle pain, occasionally severe, and incapacitating; joint swelling; low-energy femoral shaft and subtrochanteric fractures
- Nervous system: dizziness, spinning sensation (vertigo)
- Pulmonary: Acuteasthma exacerbations
- Skin: Rash (occasionally with photosensitivity), itching, hair loss, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis
- Special Senses: Uveitis, scleritis, or episcleritis, cholesteatoma of the external auditory canal (focal osteonecrosis)
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Osteosan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- bloating or fullness in the stomach
- change in ability to taste food
- swelling of the joints, hands, or legs
Baseline levels of calcium and bone mineral density should be established before therapy begins, with follow-up testing at 6 to 12 months post-therapy. Calcium at baseline and continual monitoring is needed if hypocalcemia risk is recurring. The clinician should decrease the dose or discontinue therapy if hypocalcemia occurs during treatment. Magnesium and phosphorus require monitoring at regular intervals.
The physician should offer some form of a drug-holiday to patients on Osteosan therapy. The accumulation of Osteosan in the kidney allows for persistent anti-fracture benefits even after cessation of therapy. Current recommendations suggest tailoring the drug holiday length to the individual patients. The average drug-holiday in low-risk patients is 3 to 5 years. It also bears mention that Osteosan is an extremely safe drug, and the benefits of continued therapy often outweigh the benefits of a drug holiday.
There are some more-serious but very rare health conditions associated with Osteosan:
- Osteonecrosis of the jaw - when the mouth fails to heal quickly, usually following invasive dental procedures
- Atypical (unusual) broken bones in the thigh - a break to the thigh bone that occurs with little or no force after taking the medication for a long time
If you are prescribed Osteosan, your doctor has decided the benefit of taking the treatment outweighs any risks.
It's perfectly natural to feel concerned and unsure, but be reassured that your risk of these is very small. Our specialist nurses are here for you, if you need to talk through your concerns and find out more about your risk.
What other drugs will affect Osteosan (Binosto, Fosamax)?
Tell your doctor about all your current medicines and any you start or stop using, especially:
This list is not complete. Other drugs may interact with Osteosan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Talk with your doctor about the best dosing schedule for your other medicines.