Osify

Approved Medical Uses:

• Osteoporosis (postmenopausal, senile, or corticosteroid-induced):
  Used as a calcium supplement to reduce bone loss and support bone mineral density.
• Osteopenia:
  As a preventive agent to delay progression to osteoporosis.
• Bone Fracture Healing:
  Supports bone regeneration in traumatic or surgical fractures.
• Periodontal Bone Loss:
  Adjunct in treating alveolar bone loss in dental or periodontal conditions.
• Pregnancy & Lactation Support:
  Used to meet increased calcium demand during pregnancy and breastfeeding (under physician supervision).
• Rickets & Osteomalacia:
  Supportive therapy when dietary calcium intake is insufficient.

Clinically Accepted (Off-label) Uses:

• Bone health maintenance in malabsorption syndromes or chronic inflammatory diseases (e.g., IBD).
• Nutritional supplementation in elderly patients at risk of hypocalcemia or reduced bone turnover.

Route of Administration: Oral

Adults:

• Standard Dose: 500–1000 mg elemental calcium daily (in divided doses), usually taken with meals.
• Postmenopausal Osteoporosis: 500 mg twice daily along with 800–1000 IU of vitamin D.

Elderly:

• No specific adjustment required, but renal function and calcium levels should be monitored.

Pregnancy and Lactation:

• Typically 1,000–1,300 mg elemental calcium daily is recommended. OHC may be used if dietary calcium is inadequate.

Pediatrics:

• Use based on age and calcium requirement:
• Ages 4–8: 800 mg/day
• Ages 9–18: 1,300 mg/day
• Not usually first-line; use only under physician guidance.

Renal Impairment:

• Mild to Moderate: Use with caution. Monitor calcium and phosphate levels.
• Severe: Contraindicated due to risk of hypercalcemia and vascular calcification.

Duration of Use:

• Long-term supplementation may be needed for chronic bone conditions.
• Periodic re-evaluation of calcium and bone mineral density is recommended.

Ossein Hydroxyapatite is a bioavailable complex that provides both the organic and inorganic components of natural bone. It contains elemental calcium and phosphate in a hydroxyapatite form, along with type I collagen and trace elements like zinc and magnesium. Upon ingestion, the complex is absorbed and incorporated into bone, supporting bone matrix formation and mineralization. It stimulates osteoblastic activity and helps restore the balance between bone resorption and formation, thereby reducing bone loss and improving bone strength.

• Absorption: Approximately 20–30% of elemental calcium is absorbed in the intestine; increased when taken with food.
• Distribution: Widely distributed in bone and teeth; minimal in soft tissues.
• Metabolism: Not metabolized; incorporated into bone or excreted.
• Half-life: Calcium in plasma is tightly regulated; bone turnover half-life is measured in months.
• Elimination:
• Unabsorbed calcium is excreted in feces.
• Absorbed calcium is primarily excreted by the kidneys under hormonal regulation (PTH, calcitonin, vitamin D).

• Pregnancy: Considered safe when used as a supplement within recommended daily allowances. No FDA pregnancy category assigned for OHC specifically, but calcium is essential during pregnancy.
• Lactation: Safe during breastfeeding; calcium requirements are higher and OHC can be used if dietary intake is insufficient. No harmful excretion into breast milk is known at standard doses.

• Primary Class: Bone and Mineral Metabolism Regulator
• Subclass: Natural calcium-phosphate complex (derived from bovine bone matrix)

• Known hypersensitivity to ossein, hydroxyapatite, or bovine-derived materials
• Hypercalcemia or hypercalciuria
• History of calcium-containing kidney stones
• Severe renal impairment (eGFR <30 mL/min/1.73 m²)
• Sarcoidosis or other granulomatous diseases with risk of hypercalcemia

• Hypercalcemia Risk: Avoid excessive total daily calcium intake from diet and supplements.
• Renal Impairment: Increased risk of hypercalcemia and vascular calcification.
• Drug Absorption Interference: Calcium can impair absorption of some medications (e.g., iron, levothyroxine, tetracyclines).
• Periodic Monitoring: Serum calcium, phosphate, renal function, and urinary calcium excretion should be monitored in long-term use.

Common (usually mild):

• Gastrointestinal: Bloating, constipation, flatulence, nausea
• Metallic taste

Less Common:

• Hypercalcemia (especially if overdosed)
• Kidney stones (with prolonged high intake)
• Abdominal pain

Rare:

• Hypersensitivity reactions (rash, urticaria)

Onset: GI symptoms typically occur early; hypercalcemia may develop over weeks with overuse.

• Tetracyclines, Quinolones: Reduced antibiotic absorption—separate by 2–4 hours.
• Levothyroxine: Calcium reduces thyroid hormone absorption—separate by 4 hours.
• Iron, Zinc Supplements: Compete with calcium for absorption.
• Thiazide Diuretics: May increase calcium retention—monitor serum calcium.
• Digoxin: Hypercalcemia may enhance digoxin toxicity—monitor levels if combined.

• Endocrine Society & AACE (2023–2024): Reaffirmed calcium supplementation (including OHC) in osteoporosis as effective when combined with vitamin D and lifestyle measures.
• WHO Recommendations (2023): Supports use of bioavailable calcium forms in populations with low dietary calcium intake.
• FDA Advisory (2022): Cautions against calcium over-supplementation due to cardiovascular concerns—highlighting importance of individualized dosing.

• Temperature: Store at 20°C to 25°C (68°F to 77°F)
• Humidity: Keep dry; avoid humid environments
• Light: Protect from direct sunlight
• Container: Keep in tightly closed original packaging
• Handling: No reconstitution required; oral tablets or chewable forms ready for direct use