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Study of Doxycycline Bone and Joint Penetration in Patients Undergoing Total Hip Arthroplasty for Hip Osteoarthritis

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study involves people who need a total hip arthroplasty because of coxofemoral osteoarthritis, a form of arthritis that damages the joint where the thigh bone meets the pelvis. The medication being examined is the antibiotic doxycycline, taken as a 200 mg oral tablet.

The purpose is to gather reliable data on how well the drug reaches bone and joint fluid in patients without infection. Participants will receive the study drug before their scheduled surgery, and during the operation small samples of blood, bone and joint fluid will be collected to compare drug levels. Simple explanations: “cancellous bone” is the spongy inner part of bone, “cortical bone” is the hard outer layer, and “synovial fluid” is the lubricating liquid inside the joint. The study follows participants for a short period around the surgery to complete the measurements.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment in the study

    After joining the study, you will sign the required forms and confirm that you meet the eligibility criteria for total hip arthroplasty because of coxofemoral osteoarthritis.

  2. Step 2

    Baseline assessment

    The study team will record your medical history, current medications, and any allergies.

    A blood sample may be taken to establish baseline levels of the study drug in your bloodstream.

  3. Step 3

    Receiving the study medication

    You will be given a tablet containing doxycycline.

    Each tablet contains 200 mg of the active ingredient and is taken by mouth.

  4. Step 4

    Taking the medication

    The tablet is to be swallowed whole with water.

    The dosage is 200 mg taken orally as directed by the study protocol, typically a single dose taken before your scheduled surgery.

  5. Step 5

    Undergoing total hip arthroplasty

    You will have the hip replacement operation performed by the surgical team.

    The procedure is done to treat the osteoarthritis of the hip joint.

  6. Step 6

    Sample collection during surgery

    While the surgeon is operating, small pieces of bone and joint fluid will be collected.

    Samples include cancellous bone (the spongy part of bone), cortical bone (the hard outer layer), and synovial fluid (the fluid that lubricates the joint).

    These samples are used to measure how much doxycycline has entered the bone and joint tissues.

  7. Step 7

    Post‑operative monitoring

    After surgery, you will stay in the hospital for routine recovery monitoring.

    Additional blood samples may be taken to compare drug levels in the blood with those found in the bone and joint samples.

  8. Step 8

    Final study visit

    Once you have recovered sufficiently, you will attend a final visit where the study team will review the collected data and complete any remaining questionnaires.

Who can join the trial?

5 criteria

  • Be between 18 and 80 years old.
  • Be scheduled for an elective hip replacement surgery because of hip joint arthritis (also called coxarthrosis).
  • Provide a signed informed consent form, meaning you agree in writing after understanding the study.
  • Be eligible for French social insurance, which is the national health coverage system in France.
  • Be able to fully understand the study and agree to follow its requirements and constraints.

Who cannot join the trial?

14 criteria

  • Any allergy or strong reaction (hypersensitivity) to doxycycline, its ingredients, or other drugs in the same family (tetracycline antibiotics) means you cannot join the study.
  • If you cannot safely have surgery because of a medical reason (contraindication to surgery), you are excluded.
  • People who have had an infection in the hip joint or bone related to a previous hip replacement are not allowed to participate.
  • If you have taken any antibiotics within the month before the planned surgery, you cannot be in the trial.
  • Anyone who does not take the study drug doxycycline exactly as the study plan requires is excluded.
  • Family members or close relatives of the doctors, nurses, pharmacists, or study coordinators cannot take part.
  • Conditions that make it hard for your body to absorb medicines (malabsorption syndrome), such as stomach surgery (e.g., sleeve or removal of part of the colon called a colectomy) or use of certain antacids (medicines containing magnesium, aluminum, calcium, oxides, or hydroxides) or oral iron pills, will keep you from participating.
  • People who are very underweight (Body Mass Index less than 21) or have low blood protein levels (serum albumin under 30 g/L) are excluded.
  • Kidney problems that lower the kidney’s filtering ability (GFR less than 60 mL/min/1.73 m²) mean you cannot join.
  • If you cannot swallow pills or take doxycycline by mouth, you are not eligible.
  • Women who are pregnant or are feeding a baby (breastfeeding) cannot be part of the study.
  • Women who can still have children (child‑bearing age) must use reliable birth control (such as a daily contraceptive pill or an intra‑uterine device); otherwise they are excluded.
  • People who are under legal protection, such as guardianship, curatorship, or conservatorship, cannot take part.
  • If you have an active infection when you are scheduled for the hip surgery, you are not allowed to join the trial.
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Investigated drugs

DOXYCYCLINE BIOGARAN
This is an oral tablet that contains the antibiotic doxycycline. In the study it is taken by patients so researchers can measure how much of the drug reaches the bone and joint tissues. The goal is to see how well doxycycline can penetrate bone in people who do not have an infection. DOXYCYCLINE ARROW
This product is also an oral doxycycline tablet. Participants receive it during the trial to help scientists understand the amount of antibiotic that can enter bone and joint areas. The information will show how effectively doxycycline moves from the bloodstream into bone. DOXYCYCLINE TEVA
This is another form of oral doxycycline, provided as a tablet. The trial uses it to assess the level of drug that reaches cancellous (spongy) bone in patients without infection, giving insight into the drug’s ability to get into bone tissue. DOXYCYCLINE SANDOZ
This medication is an oral tablet of doxycycline. It is given to study participants so researchers can evaluate how much of the antibiotic can be found inside bone and joint structures, helping to determine its penetration characteristics. GRANUDOXY
Granudoxy is an oral doxycycline tablet. In the study it is used to measure the concentration of doxycycline that reaches bone and joint sites, providing data on the drug’s ability to enter bone in non‑infected individuals.

What is already known about the treatment

  • DOXYCYCLINE BIOGARAN 100 mg, comprimé pelliculé sécable

    This medication is taken by mouth as a film‑coated tablet that can be split, delivering 100 mg of doxycycline per dose. Doxycycline has been in use for many decades and is widely described in medical literature. It is primarily prescribed to treat a range of bacterial infections such as respiratory, skin and urinary tract infections. The drug works by stopping bacteria from making the proteins they need to grow and belongs to the tetracycline class of antibiotics.

  • DOXYCYCLINE ARROW 100 mg, comprimé pelliculé

    This product is an oral film‑coated tablet of 100 mg doxycycline that is swallowed whole. Doxycycline is a well‑known antibiotic with extensive research support. It is commonly used for bacterial infections of the lungs, skin, and urinary system. It prevents bacterial protein formation, inhibiting growth, and is classified as a tetracycline antibiotic.

  • DOXYCYCLINE TEVA 100 mg, comprimé sécable

    This drug is administered orally as a tablet that can be split, providing 100 mg of doxycycline per dose. Doxycycline is an established medicine with a long history in clinical use and research. It is mainly indicated for treating various bacterial infections, including those of the respiratory tract and skin. It acts by blocking bacterial protein synthesis and is part of the tetracycline antibiotic family.

  • DOXYCYCLINE SANDOZ 100 mg, comprimé sécable

    This medication comes as an oral tablet that can be divided, delivering 100 mg of doxycycline each time. Doxycycline is a long‑standing antibiotic that is well documented in scientific studies. It is used to treat many bacterial infections such as those affecting the lungs, skin and urinary tract. The drug stops bacteria from producing essential proteins, and it is categorized as a tetracycline antibiotic.

  • GRANUDOXY 100 mg, comprimé pelliculé sécable

    This product is an oral film‑coated tablet, split‑able, providing a 100 mg dose of doxycycline. Doxycycline is a widely recognized antibiotic with extensive literature support. It is indicated for treating a broad range of bacterial infections, including respiratory and skin infections. It works by preventing bacteria from making proteins they need to survive and belongs to the tetracycline class of antibiotics.

Investigated diseases

Coxofemoral osteoarthritis - Coxofemoral osteoarthritis is a degenerative condition affecting the hip joint. It begins with the gradual loss of the smooth cartilage that covers the ends of the thigh bone and the socket. As the cartilage thins, the bones rub together, causing pain and stiffness, especially during movement. Over time the joint space becomes narrower and small bone growths called osteophytes may develop. The condition often leads to reduced flexibility and difficulty walking.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524744-36-00Protocol code25-0320Estimated enrolment30 patientsSponsorCentre Hospitalier Universitaire De Caen Normandie

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