Ibandronate is a member of the bisphosphonate class of drugs for treatment of osteoporosis. It is indicated for treatment of osteoporosis of the spine. It is not indicated for prevention of osteoporosis. It was not shown to prevent peripheral fractures in its studies so it should not be used to treat someone who has osteoporosis of the hip unless there are no other options. It is available as an oral tablet given once monthly and an IV given once every 3 months.

Indications from product label
Treatment of Postmenopausal Osteoporosis
Boniva Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, Boniva increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

Treatment of Postmenopausal Osteoporosis
Boniva was tested 1952 postmenopausal women with osteoporosis whose age ranged from 55 to 80 years. The study lasted for 3 years. All subjects received calcium and vitamin D, half the Boniva treated women took a daily tablet while the others took a lager does intermittently.

The rate of new vertebral fractures in the placebo group was 96 per 1,000 vs. 47 per 1,000 in the combined Boniva group. This finding was statistically significant representing a 52% relative risk reduction with an absolute risk reduction of 4.9%. To prevent one new vertebral fracture with Boniva requires treatment of 20 women like those in the study for 3 years.

Boniva did not have a significant effect on the rate of hip or peripheral fractures.

Bone density increased significantly after 3 years on Boniva 6.4% in the spine, 3.1% at the total hip and by 2.6% at the femoral neck.

Intravenous Boniva
Boniva is also available IV in a 3 mg dose every 3 months. This is also very well tolerated, much better than Reclast. It is considered by the US FDA to be the equivalent to the oral dose. It is an alternative for someone with spinal osteoporosis that cannot be treated with oral agents and is intolerant of Reclast.

Warnings
Upper Gastrointestinal Adverse Reactions

  • Boniva, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Boniva should be avoided in patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers)
  • Esophageal adverse experiences, such as esophagitis, esophageal ulcers, and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.

In the research studies of this drug there were no significant side effects including gastrointestinal. It was better tolerated than any other bisphosphonate tested and this is a major advantage of this drug. We did not exclude women with GERD or gastritis from the large registration study that had over 2000 patients. The rate of stomach complaints was the same in both groups. The same holds for musculoskeletal pain. There were equal numbers of women in both placebo and treatment groups with this symptom meaning that ibandronate does not cause it any more often than placebo does. My clinical experience with 2.5 mg daily dose of Boniva is similar. It almost never upset the stomach. Today everyone uses the once monthly 20 mg tablet. That dose has resulted in stomach upset in some people, probably because the dose is so high. It is still possible to obtain the 2.5 mg tablets and if not, the 20 mg tablets can be compounded into smaller doses’.

Warning
Hypocalcemia and Mineral Metabolism
Boniva Injection may cause a decrease in serum calcium values. Treat hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism before starting Boniva Injection therapy. Adequate intake of calcium and vitamin D is important in all patients. It is recommended that patients receive supplemental calcium and vitamin D if dietary intake is inadequate.

Warning
Anaphylactic Reaction
Cases of anaphylaxis, including fatal events, have been reported in patients treated with Boniva Injection. Appropriate medical support and monitoring measures should be readily available when Boniva Injection is administered. If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment.

Warning
Renal Impairment
Treatment with intravenous bisphosphonates has been associated with renal toxicity manifested as deterioration in renal function and acute renal failure. Although no cases of acute renal failure were observed in controlled clinical trials in which intravenous Boniva was administered as a 15- to 30-second bolus, acute renal failure has been reported postmarketing. Do not administer Boniva Injection to patients with severe renal impairment (creatinine clearance less than 30 mL/min). Obtain serum creatinine prior to each Boniva Injection. After Boniva Injection, assess renal function, as clinically appropriate, in patients with concomitant diseases or taking medications that have the potential for adverse effects on the kidney. Boniva Injection should be withheld in patients with renal deterioration.

Warning
Renal Impairment

Treatment with intravenous bisphosphonates has been associated with renal toxicity manifested as deterioration in renal function and acute renal failure. Although no cases of acute renal failure were observed in controlled clinical trials in which intravenous Boniva was administered as a 15- to 30-second bolus, acute renal failure has been reported postmarketing. Do not administer Boniva Injection to patients with severe renal impairment (creatinine clearance less than 30 mL/min). Obtain serum creatinine prior to each Boniva Injection. After Boniva Injection, assess renal function, as clinically appropriate, in patients with concomitant diseases or taking medications that have the potential for adverse effects on the kidney. Boniva Injection should be withheld in patients with renal deterioration.

Warning
Tissue Damage Related to Inappropriate Drug Administration

  • Boniva Injection must only be administered intravenously. Care must be taken not to administer Boniva Injection intra-arterially or paravenously as this could lead to tissue damage.
  • Do not administer Boniva Injection by any other route of administration. The safety and efficacy of Boniva Injection following non-intravenous routes of administration have not been established.

Warning
Osteonecrosis of the Jaw

Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates, including Boniva Injection. Most cases have been in cancer patients treated with intravenous bisphosphonates undergoing dental procedures. Some cases have occurred in patients with postmenopausal osteoporosis treated with either oral or intravenous bisphosphonates.

This is a very rare occurrence with Boniva even when given IV.

Warning
Musculoskeletal Pain

Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Boniva and other bisphosphonates. The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping the bisphosphonate.

I think this is a real side effect of all osteoporosis therapies and it is due to a lack of calcium and magnesium availability for use by the muscle, ligaments, and tendons and probably bone too. Optimizing calcium, magnesium and vitamin D nutrition is my approach to this issue when it happens. Splitting the dose of minerals between the morning and bedtime is important but the vitamin D can be taken once daily. A typical suggestion I make for patients complaining of this is to take 1 calcium citrate tablet and one 500 mg magnesium oxide capsule in the morning with vitamin D3 plus 1 calcium citrate tablet and 1 magnesium oxide capsule at night before bed. Often this simple remedy resolves the problem.

Warning
Atypical Subtrochanteric and Diaphyseal Femoral Fractures Atypical, low-energy, or low-trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture.

These occur also exclusively in Fosamax treated people, mostly women. I have not seen them in anyone on Boniva, just Fosamax.