A randomized, double-blind, placebo-controlled study evaluating the analgesic effects of the Gastrolith, in osteoporotic patients suffering from recent skeletal pain caused by vertebral fractures

A multi-center study — participating medical centers:

• Pain Clinic, Hadassah Medical Center, Jerusalem, Israel.
• The Bone and Mineral Metabolism Unit and Pain Clinic, Rambam Medical Center, Haifa, Israel.
• Pain Clinic, Sourasky Medical Center, Tel-Aviv, Israel.
• Pain Laboratory, Soroka Medical Center, Beer-Sheva, Israel.
• Pain Clinic, Clalit Health Services – South District, Israel.

Osteoporosis is a disease in which the bone structure changes and bone mass decreases. As a result, the bone gets weaker and tends to break more easily. Although the fractures may occur at multiple sites, vertebral collapse is one of the most common osteoporotic fractures. Fractures caused by osteoporosis do not cause permanent disability. However, they cause difficulty in daily functioning and affect overall quality of life. The standard of care for painful osteoporotic vertebral fracture is usually conservative non-surgical management consisting of bed rest and analgesic medication for controlling the pain.

This study was designed to examine the ability of the Gastrolith to relieve pain and to improve the quality of life and the daily functioning of patients suffering from osteoporotic vertebral fracture.

• A randomized, double-blind study.
• Includes 80 subjects aged 18-90: One group receives the Gastrolith (amorphous calcium carbonate) and the control group receives crystalline calcium carbonate (placebo).

A randomized, two phase, adaptive then crossover open-label, study comparing amorphous calcium carbonate (ACC) supplement versus commercially available crystalline calcium supplements (CCS) in the management of primary hypoparathyroidism.

Professor Sophia Ish-Shalom, Rambam Medical Center, The Bone and Mineral Metabolism Unit

The parathyroid glands belong to the endocrine system of the human body. In the human body there are four parathyroid glands that are located in the neck, on the sides of the thyroid gland. The role of the parathyroid glands is to regulate the level of calcium in the body. This is done by the secretion of the parathyroid hormone (PTH) — when the level of calcium in the blood falls, the gland secretes the hormone that elevates the level of calcium in the blood. In patients with hypoparathyroidism, the parathyroid glands do not produce enough PTH hormone, and as a result, their blood calcium level is too low. The management of the disease usually involves supplementation of large amounts of calcium and vitamin D.

This study aims to test whether calcium blood levels of patients with hypoparathyroidism can be regulated using lower doses of calcium from amorphous calcium carbonate compared to crystalline calcium carbonate and by that, improve their overall quality of life.

• A randomized, two–phase, adaptive then crossover, open-label study.
• Includes 20 participants (10 in each phase).

A prospective, randomized, parallel, double-blind, controlled pilot study comparing the effect of amorphous calcium carbonate (ACC) versus placebo on functional outcome and radiographic healing time of distal radius fractures

Dr. Omri Lubovsky, The Hand Clinic, Orthopedic Department, Barzilai Medical Center, Ashkelon

Wrist fractures are quite common and are usually accompanied by pain, swelling and restriction of movement of the wrist. The recovery from these fractures can take many weeks.

Amorphous calcium carbonate has a unique structure that allows it to be absorbed efficiently in the gastrointestinal tract. The high bioavailability of amorphous calcium carbonate in the body can accelerate bone remodeling that occurs after bone fracture and in additional situations.

This study was designed to test the effect of amorphous calcium carbonate on bone fusion and recovery rate following a fracture in the wrist, and thus to improve the current standard-of-care management and decrease the time required to return to normal daily functioning.

• Randomized, double -blind study.
• Includes 50 subjects aged 50-90; one group receives amorphous calcium carbonate and the control group receives placebo.