Young People Get Osteoporosis Too 

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to zoledronic acid or other medications used to treat a high blood calcium or osteoporosis. Also tell your doctor and pharmacist if you are allergic to any other substances, such as other drugs, foods, preservatives, or dyes.

Pregnancy—Zoledronic acid has not been studied in pregnant women. However, studies in animals have shown that zoledronic acid causes birth defects. Women of childbearing age should avoid becoming pregnant. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding— It is not known whether zoledronic acid passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of zoledronic acid in children with use in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of zoledronic acid in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Previous allergic reaction to zoledronic acid or other drugs —May cause severe reaction
• Asthma—Certain types of asthma may be worsened by zoledronic acid
• Heart disease—May be worsened by zoledronic acid
• Kidney disease—May be worsened by zoledronic acid

• More common
  • Black, tarry stools;  blurred vision ;  cancer progression;  chest pain;  chills;  confusion ;  convulsions;  cough;  dizziness, faintness, or lightheadedness when getting up from a lying or sitting position;  fever;  irregular heartbeat;  lack or loss of strength;  lower back or side pain;  mood or mental changes, confusion;  muscle pain or cramps ;  muscle trembling or twitching, shaking of hands, arms, feet, legs, or face;  nausea or vomiting ;  numbness and tingling around mouth, fingertips, or feet;  painful or difficult urination;  pale skin;  shortness of breath, difficult or labored breathing;  skin rash, cracks in skin at the corners of mouth, soreness or redness around fingernails and toenails ;  sore throat;  sores, ulcers, or white spots on lips or mouth;  sudden sweating ;  swollen glands;  tightness in chest;  trouble breathing with exercise;  unusual bleeding or bruising;  unusual tiredness or weakness;  wheezing;  worsening of cancer 

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Abdominal pain;  anxiety, nervousness, restlessness or irritability;  bad, unusual or unpleasant (after) taste;  back pain;  bladder pain, bloody or cloudy urine;  blistering, crusting, irritation, itching, or reddening of skin;  bone pain;  burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings;  change in taste;  cracked, dry scaly skin;  cracked lips;  constipation ;  dehydration;  diarrhea ;  difficulty swallowing;  discouragement;  dry mouth;  ear congestion;  fear or nervousness;  feeling sad, or empty;  frequent urge to urinate;  hair loss, or thinning hair;  headache;  hyperventilation;  irregular heartbeats;  joint pain, or swollen joints;  loss of appetite;  loss of interest, or pleasure;  loss of voice;  muscle pain, stiffness or difficulty in moving;  pain, swelling, or redness in joints;  partial loss of feeling;  nasal congestion, or runny nose;  seeing, hearing, or feeling things that are not there;  sleepiness or unusual drowsiness;  sleeplessness, trouble sleeping, unable to sleep;  swelling;  swelling of leg;  thirst;  trouble concentrating;  unusually cold, shivering;  vomiting ;  weight loss;  white spots on lips, tongue, or inside mouth 

  
   

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  One IV Treatment a Year May be Enough to Protect Bones from
  Osteoporosis, Study Suggests
  By JANET McCONNAUGHEY
  Associated Press Writer
  (AP) NEW ORLEANS
  
  One IV treatment a year rather than a pill a day may be enough to prevent osteoporosis, an exciting new international study suggests. The research involves a drug called zoledronic acid, which is approved for use in cancer patients to treat a condition in which calcium leaches from the bones.
  
  It will be about five years before doctors know whether the drug really does prevent fractures, because the study in Thursday's New England Journal of Medicine was only a one-year look at the medicine's effect on bone itself. The manufacturer, which paid for the research, has already begun the much larger and longer studies.
  
  But doctors who treat osteoporosis, which weakens the bones, are excited by the preliminary results. 
  
  The World Health Organization estimates that the risk of suffering a fracture related to osteoporosis over the course of life is about 40 percent for women, and 13 percent for men.
  
  "With the predicted increase in the number of older people worldwide, the number of hip fractures could rise from 1.7 million in 1990 to 6.3 million by 2050. It is estimated that 71 percent of these fractures will occur in developing countries," according to WHO, the
  United Nations health agency.
  
  Dr. Felicia Cosman, clinical director of the National Osteoporosis Foundation, said the thought of a once-a-year treatment is mind-boggling.
  
  "It's potentially a huge change in treatment _ and, I think, prevention _ of osteoporosis," Dr. Ian R. Reid of the University of Auckland, New Zealand, who led the study, which was conducted at 24 centers in 10 countries. "I think it almost comes into the category of a flu shot, rather than taking pills every day and having side effects."
  
  Over the course of a year, 351 women in New Zealand, Australia, Switzerland, Austria, Belgium, France, Germany, Italy, Sweden and Canada were given four five-minute intravenous infusions three months apart. One-sixth of the women got a placebo in all four; the others
  had at least one IV with zoledronic acid in it.
  
  All five drug treatment schedules had about the same results, and all were better than the placebo. The drug was found to slow the rate of bone less and increase bone density, and the effect persisted for at least a year after treatment, long after the medication had disappeared from the blood.
  
  Bone density was 4.3 percent to 5.1 percent higher in the spine and 3.1 percent to 3.5 percent higher in the hip than it was for patients on placebo.
  
  The drug, sold by Novartis Pharmaceuticals Corp. as Zometa, is in a class called bisphosphonates. Two other drugs in this class are used as one-a-day pills to treat osteoporosis; one also is available as a once-a-week pill.
  
  However, the pills must be taken sitting or standing straight up, before eating, and the patient has to stay upright for 30 minutes without eating or drinking. Side effects include abdominal pain, nausea, heartburn and irritation of the esophagus. And research has shown that such patients often skip their pills or do not take them according to instructions.
  
  The IV treatment has fewer side effects, Cosman said.
  
  However, she warned that women still need to make sure they get enough calcium, vitamin D and exercise.
  
  "No drug works as well in the absence of making other changes in the lifestyle," she said. "It's not like you can completely forget about bone health in between administrations of medicine."
  
  Other treatments for osteoporosis include estrogen supplements or an estrogen alternative, both of which increase bone density but apparently not as well as bisphosphonates, and a bone hormone called calcitonin. Some of these treatments are often given in pill or patch
  form.
  
  Novartis has begun enrolling patients for two big studies of the drug: a three-year study of 7,500 women who have been through menopause, and a two-year look at 4,500 men and women who already have had a hip fracture from osteoporosis.
  
  Novartis said it does not know how much the drug is likely to cost. If a version of Zometa is approved for use against osteoporosis, it will probably be given another name.
  
  Read another article regarding a story about Zometa featured on The Dateline Television Show on (8/25/02):
  
  Researchers Investigate Once-Yearly Treatment for Osteoporosis as Alternative to Daily Medication (dateline August 25, 2002)