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Study of alfacalcidol for treating secondary hyperparathyroidism in patients after gastric bypass surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on secondary hyperparathyroidism, a condition where the body produces too much parathyroid hormone after weight loss surgery. The study will test the effectiveness of alfacalcidol, a form of active vitamin D, in treating this condition in people who have undergone Roux-en-Y gastric bypass surgery. The medication being tested is called Etalpha and comes in soft capsules of different strengths (0.25, 0.5, and 1 microgram).

The purpose of this research is to determine if alfacalcidol can help normalize hormone levels in patients who develop secondary hyperparathyroidism after weight loss surgery. The study will last for 24 months, during which participants will take the medication orally once daily. Throughout the study, doctors will monitor hormone levels and bone health to see how well the treatment works.

The research will also look at how the treatment affects bone density and overall quality of life. Bone density will be measured using special scans to check if there are any changes in the spine, hip, or arm bones. Participants will complete questionnaires about their quality of life every six months during the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial phase
After joining the study, you will be evaluated for secondary hyperparathyroidism (a condition where certain hormone levels are elevated due to previous gastric bypass surgery).
Your vitamin D levels must be above 50 nmol/l to participate.
Initial measurements will include bone density scanning and blood tests to check hormone and calcium levels.
Step 2
Treatment assignment
You will receive alfacalcidol (active vitamin D) in soft capsule form.
The medication will be taken by mouth in one of three possible doses: 0.25 micrograms, 0.5 micrograms, or 1 microgram.
You will continue taking your standard supplements during the study period.
Step 3
6-month follow-up
Every 6 months, you will complete a quality of life questionnaire called OBESI-Q.
Regular blood tests will monitor your hormone and calcium levels.
Step 4
1-year evaluation
After one year, you will undergo a bone density scan to check for any changes in bone strength.
Blood tests will continue to monitor your hormone levels and calcium.
Step 5
2-year final evaluation
At the end of two years, final measurements will be taken to assess hormone levels and bone density.
This will determine if the treatment has helped normalize your hormone levels.
A final quality of life questionnaire will be completed.

Who can join the trial?

7 criteria

Must be 18 years or older
Must have undergone Roux-en-Y gastric bypass surgery (a weight loss surgery that reduces stomach size and redirects part of the small intestine)
Must have secondary hyperparathyroidism (a condition where the parathyroid glands produce excess hormones) that developed after the surgery
Must have adequate vitamin D levels (above 50 nmol/l) in the blood
Must be taking only standard supplements following surgery
Can be either male or female (including both pre- and post-menopausal women)
Must be willing and able to provide informed consent (written permission) before participating in any study procedures

Who cannot join the trial?

15 criteria

Age below 18 years or above 65 years
Pregnant or breastfeeding women
Current or planned pregnancy during the study period
Known allergies to alfacalcidol or similar medications
Severe kidney disease (as it may affect calcium metabolism)
Liver disease that affects medication processing
History of primary hyperparathyroidism (overactive parathyroid glands)
Taking medications that could interact with alfacalcidol
Participation in another clinical trial within the last 30 days
Active cancer or cancer treatment
Uncontrolled high blood calcium levels
History of kidney stones
Inability to follow study procedures
Mental conditions that could affect ability to provide informed consent
Substance abuse or addiction

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Frisius
Heerenveen, The Netherlands
Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands
Verified
Rijnstate Ziekenhuis Stichting
Arnhem, The Netherlands

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Investigated drugs

Alfacalcidol is a form of active vitamin D that helps control parathyroid hormone levels in the body. It is used to treat secondary hyperparathyroidism, a condition where the parathyroid glands become overactive after bariatric surgery (specifically after Roux-en-Y gastric bypass). This medication helps the body maintain proper calcium balance and bone health, which can be affected after weight loss surgery.

Alfacalcidol

What is already known about the treatment

Alfacalcidol – A synthetic vitamin D analog that is administered orally or intravenously to treat conditions related to vitamin D deficiency and calcium metabolism disorders. This medication is widely used in clinical practice for managing secondary hyperparathyroidism, particularly in patients who have undergone bariatric surgery or have kidney disease. Alfacalcidol works by increasing calcium absorption in the intestines and promoting proper bone mineralization, while also helping to regulate parathyroid hormone levels in the body. As a member of the vitamin D derivative class of medications, it is activated in the liver and does not require kidney activation like natural vitamin D, making it particularly effective for patients with impaired kidney function.

Investigated diseases

Secondary Hyperparathyroidism - A condition where the parathyroid glands produce excessive amounts of parathyroid hormone (PTH) in response to low calcium levels in the body. This condition often develops as a compensatory mechanism when the body struggles to maintain proper calcium balance. In cases following gastric bypass surgery (RYGB), it typically occurs due to reduced calcium absorption in the digestive system. The parathyroid glands become overactive in an attempt to normalize calcium levels in the blood. Over time, this can affect bone health as the body tries to maintain calcium balance by drawing calcium from bone tissue. The condition can progress gradually and may impact multiple body systems involved in calcium regulation.