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Calcium Lactate Gluconate

This article discusses the use of Calcium Lactate Gluconate, a form of calcium, in clinical trials for the treatment of post-menopausal osteoporosis. While the main focus of the trial is on a different drug (BP16), Calcium Lactate Gluconate is included as part of the study medication. The trial aims to compare the effectiveness, safety, and other factors of BP16 with an existing treatment (EU-Prolia) in women with post-menopausal osteoporosis.

Table of Contents

What is Calcium Lactate Gluconate?

Calcium Lactate Gluconate is a calcium supplement that is used to prevent or treat low calcium levels in the body. It’s also known as calcium lactogluconate[1]. This compound is a combination of calcium, lactic acid, and gluconic acid, which helps in better absorption of calcium in the body.

Medical Uses

While the primary focus of the clinical trial data is on a different medication (denosumab), it provides context for conditions where calcium supplements might be beneficial. The main condition mentioned is:

  • Post-Menopausal Osteoporosis: This is a condition where bones become weak and brittle, primarily in women after menopause. Calcium supplements, including Calcium Lactate Gluconate, can be crucial in managing this condition[1].

Calcium supplements are generally used to:

  • Prevent or treat calcium deficiencies
  • Support bone health
  • Aid in the prevention of osteoporosis

Composition

The clinical trial data mentions a product that contains Calcium Lactate Gluconate along with other substances. The composition includes:

  1. Calcium Lactate Gluconate: The primary calcium source[1].
  2. Calcium Carbonate: Another form of calcium, also known as chalk[1].
  3. Ascorbic Acid: Also known as Vitamin C, which can aid in calcium absorption[1].

Administration

According to the clinical trial data, the medication containing Calcium Lactate Gluconate is administered orally[1]. The maximum daily dose amount is listed as 2 grams, with a maximum total dose amount of 1148 grams over a treatment period of 82 weeks[1].

Clinical Trial Information

While the clinical trial described in the data is not specifically about Calcium Lactate Gluconate, it provides context for research in the field of osteoporosis treatment. The trial is comparing a medication called BP16 with EU-Prolia® (denosumab) in post-menopausal women with osteoporosis[1].

Potential Benefits

While not directly studied in this trial, calcium supplements like Calcium Lactate Gluconate can potentially offer the following benefits:

  • Improved bone mineral density
  • Reduced risk of fractures
  • Support for overall bone health

Safety Considerations

As with any medication or supplement, it’s important to consider safety. While the trial data doesn’t provide specific safety information for Calcium Lactate Gluconate, general considerations for calcium supplements include:

  • Potential interactions with other medications
  • Possible side effects such as constipation or stomach upset
  • The importance of not exceeding recommended doses

Always consult with your healthcare provider before starting any new supplement regimen, including Calcium Lactate Gluconate.

Aspect Details
Study Type Phase III, Randomized, Double-Blind, Parallel Group, Multicenter Study
Main Condition Post-Menopausal Osteoporosis
Primary Objectives Compare BP16 and EU-Prolia in terms of bone mineral density change and serum C-telopeptide levels
Key Inclusion Criteria Post-menopausal women, 55-80 years old, T-score between -2.5 and -4.0 at lumbar spine
Study Duration 78 weeks
Primary Endpoints Percent change in lumbar spine bone mineral density at Week 52, AUEC of sCTX from Week 0 to Week 26
Calcium Lactate Gluconate Role Included as part of study medication, likely as a calcium supplement

FAQ

  • What is the purpose of including Calcium Lactate Gluconate in this clinical trial? Calcium Lactate Gluconate is included as part of the study medication. While not the main focus, it likely serves as a calcium supplement, which is important for bone health in osteoporosis patients.
  • Who can participate in this clinical trial? The trial is open to post-menopausal women aged 55 to 80 years with evidence of osteoporosis, specifically a T-score between -2.5 and -4.0 at the lumbar spine. Participants must weigh between 50 to 90 kg and have at least 3 intact, non-fractured vertebrae in the L1-L4 region.
  • What are the main objectives of this clinical trial? The main objectives are to demonstrate therapeutic and pharmacodynamic equivalence between BP16 and EU-Prolia in terms of change in bone mineral density at Week 52 and in serum C-telopeptide levels up to Week 26.
  • How long does the clinical trial last? The trial lasts for 78 weeks (about 1.5 years), with key assessments at Weeks 26, 52, and 78.
  • What are some of the exclusion criteria for this trial? Participants cannot have a history of hypersensitivity to denosumab or its components, previous exposure to denosumab, a T-score below -4.0 at specific bone sites, or prior use of any anti-osteoporotic treatment. For a full list of exclusion criteria, please refer to the study protocol.

Ongoing Clinical Trials on Calcium Lactate Gluconate

  • Study on the Effects of BP16 and Denosumab in Women with Post-Menopausal Osteoporosis

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Estonia Hungary Latvia Poland Slovakia

  • Study of AZD9550 and AZD6234 combination for weight loss in people with obesity or overweight with health complications

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Safety and Effects of AZD9550 for Overweight and Obese Patients with Non-Alcoholic Steatohepatitis (NASH) with or without Type 2 Diabetes

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Sweden

Glossary

  • Osteoporosis: A condition where bones become weak and brittle, increasing the risk of fractures. It's common in post-menopausal women due to hormonal changes.
  • Calcium Lactate Gluconate: A form of calcium used as a dietary supplement to support bone health.
  • Bone Mineral Density (BMD): A measure of how much calcium and other minerals are in your bones. Lower BMD indicates weaker bones.
  • T-score: A number that shows how much your bone density is above or below average. In osteoporosis, T-scores are typically low.
  • Denosumab: A medication used to treat osteoporosis by helping to strengthen bones and reduce the risk of fractures.
  • Pharmacodynamics (PD): The study of how a drug affects the body.
  • Pharmacokinetics (PK): The study of how the body processes a drug.
  • Serum C-telopeptide (sCTX): A marker in the blood that indicates the rate of bone turnover or breakdown.
  • Lumbar Spine: The lower part of the spine, often affected by osteoporosis.
  • DXA Scan: A type of X-ray used to measure bone density.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-bp16-and-denosumab-in-women-with-post-menopausal-osteoporosis/