Bonemass D70 mg+2800 IU

Bonemass D is indicated for the following established uses:

• Treatment of osteoporosis in postmenopausal women - reduces the incidence of vertebral, hip, and other fractures while increasing bone mineral density.
• Treatment to increase bone mass in men with osteoporosis.

Limitation of use: Bonemass D should not be used as the sole therapy for correcting vitamin D deficiency; it is intended to provide a maintenance dose of vitamin D3 alongside the anti-resorptive effect of alendronic acid, not to treat established deficiency states, which require separate, higher-dose vitamin D repletion.

This fixed-dose combination is generally prescribed once weekly maintenance dosing after adequate calcium and vitamin D status has been confirmed, and is not intended as first-line therapy in patients whose baseline calcium or vitamin D levels have not been assessed.

Each tablet of Alendronic Acid + Vitamin D3 typically contains Alendronic acid (as alendronate sodium) 70 mg combined with Vitamin D3 (cholecalciferol) 2800 IU or 5600 IU, formulated for once-weekly oral administration. Strength combinations may vary slightly by manufacturer; always check the product label for the exact composition dispensed.

Bonemass D is a fixed-dose combination product used in the management of osteoporosis. It combines alendronic acid, a nitrogen-containing bisphosphonate that slows bone loss, with vitamin D3 (cholecalciferol), which supports intestinal calcium absorption and bone mineralization. The combination is designed for once-weekly dosing to improve adherence in patients who require both anti-resorptive therapy and vitamin D supplementation.

Bonemass D is taken orally on an empty stomach, first thing in the morning, with plain water, well before any other food, beverage, or medication.

Bonemass D belongs to the therapeutic class of bisphosphonates combined with vitamin D analogues, used in bone metabolism disorders. Alendronic acid is a nitrogen-containing bisphosphonate (anti-resorptive agent), and vitamin D3 is a fat-soluble vitamin/calcium-homeostasis agent.

Alendronic Acid + Vitamin D3 combines two complementary mechanisms:

• Alendronic acid is a nitrogen-containing bisphosphonate that binds strongly to hydroxyapatite in bone and selectively inhibits osteoclast-mediated bone resorption without directly affecting bone formation. This shifts the balance of bone remodeling in favor of bone mass gain over time, increasing bone mineral density and reducing fracture risk.
• Vitamin D3 (cholecalciferol) is hydroxylated in the liver and kidney to its active form, which promotes intestinal absorption of calcium and phosphate, supports normal bone mineralization, and helps maintain adequate serum calcium needed for the anti-fracture benefit of alendronic acid to be fully realized.

Oral bioavailability of the alendronic acid component is low (further reduced by food, calcium, and antacids), which is why Alendronic Acid + Vitamin D3 must be taken on a strictly empty stomach.

Bonemass D must be swallowed whole with a full glass of plain water, first thing in the morning, at least 30 minutes before any food, drink, or other oral medication. The patient must remain upright (sitting or standing) for at least 30 minutes afterward and must not lie down. See Dosage and Administration for the complete instructions.

Clinically significant interactions with Bonemass D include:

• Calcium supplements, antacids, and multivalent cation products (magnesium, iron, aluminum): significantly reduce absorption of the alendronic acid component if taken too close together; separate administration by at least 30 minutes (preferably longer for calcium).
• Aspirin and NSAIDs: concurrent use with alendronic acid may increase the risk of upper gastrointestinal irritation and adverse effects; use with caution.
• Orlistat, bile acid sequestrants (e.g., cholestyramine), and mineral oil: may reduce intestinal absorption of the vitamin D3 component.
• Anticonvulsants (e.g., phenytoin, phenobarbital) and rifampicin: may increase hepatic catabolism of vitamin D3, reducing its effect.
• Thiazide diuretics: may increase risk of hypercalcemia when combined with vitamin D3, particularly in patients with impaired renal function or hypoparathyroidism.
• Other oral bisphosphonates or vitamin D-containing products: avoid concurrent use to prevent additive toxicity.

Common side effects of Bonemass D include:

• Gastrointestinal effects: abdominal pain, distension, acid regurgitation, dyspepsia, nausea, diarrhea, or constipation.
• Musculoskeletal pain (bone, joint, or muscle pain), which can occasionally be severe.
• Headache.
• Esophageal irritation or reflux symptoms.

Less common but serious effects include severe esophageal reactions (esophagitis, esophageal ulcer or erosion), osteonecrosis of the jaw, and atypical femur fractures - see Precautions and Warnings for details. Hypersensitivity reactions (rash, angioedema, and rarely severe skin reactions) have also been reported.

Bonemass D is generally not indicated in premenopausal women, including during pregnancy. Available human data are insufficient to establish fetal safety; the drug is retained in bone for a prolonged period and released slowly over time, so exposure could theoretically extend beyond the treatment period. If pregnancy occurs or is planned, Bonemass D should be discontinued, and it should be used only if clearly needed and the potential benefit justifies the potential risk to the fetus; consult a physician.

It is not known whether alendronic acid is excreted in human breast milk. Because of the potential for serious adverse reactions in a nursing infant, a decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of therapy to the mother; consult a physician before use during breastfeeding.

Important precautions when using Bonemass D:

• Esophageal reactions: Severe esophagitis, esophageal ulcers, and erosions have been reported, especially if administration instructions are not followed. Discontinue and seek medical advice if new or worsening dysphagia, chest pain, or heartburn occurs.
• Osteonecrosis of the jaw (ONJ): Reported primarily in patients undergoing invasive dental procedures (e.g., extractions) during treatment, and in those with cancer, chemotherapy, corticosteroid use, or poor oral hygiene. Good oral hygiene should be maintained; dental evaluation should be considered before starting treatment in at-risk patients, and invasive dental work should be avoided during therapy where possible.
• Atypical femur fractures: Atypical, low-trauma subtrochanteric and femoral shaft fractures have been reported with long-term bisphosphonate use. New thigh, hip, or groin pain should be evaluated promptly.
• Hypocalcemia: Must be corrected before starting therapy; ensure adequate calcium and vitamin D intake throughout treatment.
• Renal impairment: Not recommended in patients with severe renal impairment (creatinine clearance below 35 mL/min).
• Hypervitaminosis D: Avoid excessive supplemental vitamin D or calcium from other sources while on therapy to prevent hypercalcemia and hypercalciuria.

Overdose of Bonemass D may cause hypocalcemia, hypophosphatemia, upper gastrointestinal symptoms (upset stomach, heartburn, esophagitis, gastritis, or ulcer), and signs of vitamin D toxicity such as nausea, vomiting, weakness, and hypercalcemia. No specific antidote exists. Milk or antacids may be given to bind alendronic acid, but vomiting should not be induced and the patient should remain fully upright. In case of suspected overdose, seek immediate medical attention or contact a poison control center right away.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly: No dosage adjustment is required based on age alone; renal function should be assessed, as many elderly patients have reduced creatinine clearance.

Renal impairment: No dosage adjustment needed for mild-to-moderate impairment; not recommended when creatinine clearance is below 35 mL/min due to lack of safety/efficacy data.

Hepatic impairment: No specific dosage adjustment studies are available; use with routine caution.

Pediatric patients: Not indicated for use in children; safety and efficacy have not been established in this population.

Duration of therapy with Bonemass D is individualized based on fracture risk, bone mineral density response, and clinical judgment. Long-term use (typically beyond 3-5 years) should be periodically reassessed by the prescribing physician, since the optimal duration has not been definitively established and the risk of atypical femur fractures may increase with prolonged use. Do not stop or extend treatment without consulting your physician.

Alendronic Acid + Vitamin D3 falls under the drug classes: Bisphosphonates (anti-resorptive bone agents) and Vitamin D analogues/supplements.

The alendronic acid component of Alendronic Acid + Vitamin D3 binds to bone mineral and inhibits osteoclast activity, reducing bone resorption and allowing bone-forming activity to gradually increase bone mass. The vitamin D3 component is converted to its active metabolite, which enhances intestinal calcium absorption and supports normal bone mineralization, complementing the anti-resorptive action of alendronic acid.

Category C

Bonemass D is not indicated for use in pediatric patients. Safety and efficacy in children and adolescents have not been established, and this combination should not be prescribed in this age group.